They are not approved for use by the FDA. We know how important it is to feel confident that your therapy device is safe to use. We are always interested in engaging with you. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. PDF Product Defect Correction - Philips I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back. If you need to change your pads in an emergency, there is a short video showing how to replace the pads cartridge at: www.philips.com/replace-aed-pads, Please pass the notice to all those who need to be aware within your organization or to any organization where HS1/Onsite/Home AED devices or pads cartridges have been transferred, (if appropriate.). English: https://forms.office.com/r/7AJ5HZnW91, French: https://forms.office.com/r/ReC8txbPPr. It is not possible to know if your pads are affected by the problem prior to use because the pads are protected by a foil seal. This could affect the prescribed therapy and may void the warranty. In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. The guidance for healthcare providers and patients remains unchanged. If the problem occurs and you do not have a spare pads cartridge, attend to the patient, providing CPR if needed, until Emergency Medical Services Personnel arrive. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). Philips HeartStart OnSite Replacement Pads Cartridge - Adult Lift out the used SMART pads cartridge. PLEASE CONTACT THE DISTRIBUTOR THAT PROVIDED THE AED, OR PHILIPS DIRECTLY WITH ANY QUESTIONS. Philips Defibrillator Recall | aedusa.com - AED USA Knowledge Philips, REF M5071A, Adult. HeartStart OnSite AED - OnSite Defibrillator | Philips There is also the potential for delayed therapy, if the appearanceof the peeled pad leads a user to not use affected pads and/or spend time searching for spare pads. The HeartStart HS1 AEDs are intended for use in public places or the home. Philips Respironics Sleep and Respiratory Care devices, new devices and repair kits produced to meet the U.S. registration demand*, devices remediated and in the hands of U.S. patients and Durable Medical Equipment providers (DMEs)**. Philips is actively working on design changes intended to eliminate the issue in the M5071A and M5072A pads. Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. No- the replacement device you have received is not affected by the recall/ field safety notice, because the foam in the device has been replaced with a new type of foam. There is also the potential for delayed therapy, if the appearanceof the peeled pad leads a user to not use affected pads and/or spend time searching for spare pads. The recall was issued due to the potential for the AED pad gel to separate from the foam/tin backing when peeled . Philips, REF M5071A, Adult. Amazon.com: Philips M5071a Pads 03 : 43 : 59 6 results for "philips m5071a pads" Results Philips HeartStart AED Defibrillator Replacement Adult Training Pads 22 $4027 FREE delivery Mon, Jul 17 Or fastest delivery Fri, Jul 14 Philips HeartStart 989803139271 Adult Training Pads II Kit 1 $10900 FREE delivery Mon, Jul 17 Or fastest delivery Fri, Jul 14 If no spare set is available, perform CPR until Emergency Medical Services Personnel arrive. PDF M5071A Adult SMART Pad Cartridge Replacement Procedure Form - Philips Once you are registered, we will share regular updates to make sure you are kept informed. This replacement reinstates the two-year warranty. We are always interested in engaging with you. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. 2. What devices have you already begun to repair/replace? For questions regarding this recall, please call AED Recall Support at 1-800-263-3342 (Option 6). All rights reserved. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a different, silicone foam. The current pads cartridge LOT # starts with a Y. This was initially identified as a potential risk to health. Get information on the Philips . M5071A SMART Pads Cartridge is designed for use in the Philips HeartStart OnSite and HS1 home defibrillator. Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. Please click, We know how important it is to feel confident that your therapy device is safe to use. With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at https://www.mdl3014preservationregistry.com, Philips will not charge the users DME supplier for the cost of the replacement device. These repair kits are not approved for use with Philips Respironics devices. Any HS1/OnSite/Home AED pad (PN:M5071A, M5072A) currently installed in or stored with an HS1/OnSite/HomeAED could experience this issue. URGENT - Medical Device Recall Product: Date: Subject: Philips M5071A (adult) and M5072A (infant/child) AED pads March 2, 2022 . Further testing and analysis on other devices is ongoing. AED Recall - Were you aware? | Courtemanche & Associates Attempts to remove or change the sound abatement foam may render the device permanently inoperative and create health hazards. It is important that you do not stop using your device without discussing with your doctor. The replacement device Ive received has the same model number as my affected device. What should I do if I am aware of an impacted Philips device in my facility, but I am not the original purchaser? First-generation DreamStation, System One and DreamStation Go devices. ** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Are these devices being removed from service? If your current pads cartridge has not expired, please keep the current pads cartridge and use it as a spare in case of emergency. If you have permanently taken your HS1/OnSite/Home AED out of service, please make a note of the Serial Number(s) of the HS1/OnSite/Home AED(s) that were taken out of service if available and contact Philips or your local Philips Representative. Product / Device Name / Model # Philips M5071A (adult) and M5072A (infant/child) for use specifically with the HeartStart HS1 AEDs/OnSite/Home AED ARTG Ref # 337264, 374814 . If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at https://www.mdl3014preservationregistry.com, Philips will not charge the users DME supplier for the cost of the replacement device. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. AED Pads Medical Device Recall Notice | Philips This also includes an in-depth review and re-assessment of data and toxicological risk-assessments prior to June 2021. If the current Adult SMART pads cartridge is not expired, please keep it as a spare to use in an emergency only. Further testing and analysis on other devices is ongoing. Are you still taking new orders for affected products? These Philips AED replacement pads are designed for adult cardiac arrest victims over 55 lbs. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the devices voice prompts during use, because the AED will audibly guide users through each step of the procedure. Use With Philips Medical Instruments: M5066A, M5067A, M5068A (HeartStart HS1 Defibrillator) Find Similar Products by Category. Amazon.com: Philips M5071a Pads Your complimentary Adult SMART pads will be provided to you. (Most of these reports, approximately 80, were received in 2021.). It is also possible that the gel could separate almost completely from the foam/tin backing when peeled. Will I be charged or billed for an unreturned unit? Easy as 1-2-3 We've equipped OnSite with integrated SMART Pads that will provide feedback to the AED so it can adapt its voice instructions to your actions and your pace. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owners Manual and the Urgent Medical Device Correction Letter/Field Safety Notice. Promotion Details * Coupon expires 7/31/23 at 11:59 pm CT. . Once Competent Authorities clear the updated Adult SMART pads, Philips will provide a complimentary updated Adult SMART Pad cartridge. Philips - M5073A Adult Training Pads Cartridge $119.00. Philips Respironics did not have conclusive data indicating that exposure to the particulates or emitted chemicals would lead to cancer. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Breaking the foil seal or opening the pads to check will quickly dry out the pads. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. It is easy to set-up and includes automatic Life Guidance features like voice prompts and CPR coaching to help guide you through the treatment of sudden cardiac arrest. The AED will step you through the necessary actions. If you purchased your device from AED4Life or AEDShop.ca, fill out the following response form and submit. If their device is affected, they should start the registration process here. Philips: regulatory.canada@philips.com or 1-800-567-1080, Reference: Gel Separation, M5071A and M5072A, HS22005R/FSN-2021-CC-EC-012. Users should continue to use the HS1 AED and pads as-is and follow the devices voice prompts during use. ** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. The AED is stored inside a red carrying case. An expiration date is marked on the front of the pads cartridge. Users should continue to use the HS1 AED and pads as-is and follow the devices voice prompts during use. Product. SKU: M5071A Individual Package Quantity: 1 ( ) Shipping: . Owners of the HS1/OnSite/Home AEDs who have not received a letter from Philips or a distributor by the end of March 2022 may contact Philips or their local Philips Representative. Once we have clearance, we will begin providing updated Adult SMART pads worldwide. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Automated external defibrillators (non-wearable), Code of Federal Regulations (CFR) Title 21 7.55, 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, Instructions for Downloading Viewers and Players, Class 2 Device Recall Philips and Laerdal brands of HeartStart HS1 Defibrillator Family. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. Should this occur, there is a possibility of insufficient therapy delivery, or of patient skin burns. What should I do if I have permanently taken my HS1/OnSite/Home AED out of service? Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. PDF URGENT: Medical Device Recall - Respiratory Homecare Solutions 1. Continue to keep your AED in service for patient use if needed. [FOR WEB] Please scroll down to view photos of affected devices if you are unsure which device you currently use. Do not hesitate to apply the pads to the patient unless the gel has almost completely separated from the backing. Philips had determined there is a need to emphasize the importance o. Philips Healthcare sent an Emergency Care and Resuscitation letter Customer Information Letter dated July 26, 2012, to all affected customers. Affected customers will be notified when the new design pad is available. Vr webbplats visas bst i senaste versionen av Microsoft Edge, Google Chrome eller Firefox. The gel may fold onto itself resulting in reduced surface . As part of our commitment to quality and patient safety, Philips Respironics is dedicated to removing product containing the affected sound abatement foam from the market. Philips Respironics has pre-paid all shipping charges. Frequently updating everyone on what they need to know and do, including updates on our improved processes. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Philips projects to release an update regarding pads later in 2022, dependent upon design activities, subcomponent availability, and regulatory approvals. You can view a short video showing how to replace the pads cartridge at the following web address. Prompts are repeated and rephrased if needed and include additional instructions to aid understanding. 2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam*. This Philips Respironics December 2022 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for VOCs, particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products. David Ferguson, Business Leader, Sleep & Respiratory Care, joined Philips in March 2021. Where to find the LOT #: Once you receive the updated Adult SMART pads cartridge, replace the current pads cartridge in your AED with the new one. What should customers do if there seems to be something wrong with a pads appearance? The potential issue is with the foam in the device that is used to reduce sound and vibration. https://www.mdl3014preservationregistry.com. As a result, testing and assessments have been carried out. What should customers do if there seems to be something wrong with a pads appearance? Please complete this request as soon as possible. The AED will audibly guide users through each step of the procedure. No. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval. PDF This document contains important information for the - Philips Philips HeartStart OnSite AED M5066A | Free Shipping | AED Superstore You can read the press release here. Philips lmnar inga utfstelser eller garantier av ngot slag med avseende p tredje parts webbplatser eller informationen dri. To read more about ongoing testing and research, please click here. The guidance for healthcare providers and patients remains unchanged. Instructions for Downloading Viewers and Players. This issue only relates to HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite), and does not involve HeartStart FRx. Attempts to remove or change the sound abatement foam may render the device permanently inoperative and create health hazards. The AED will audibly guide users through each step of the procedure. Philips or a Philips Distributor will send a letter to the customer of record. If you notice the gel beginning to separate from the foam backing as you peel, try to prevent the gel from folding onto itself if possible. Serial numbers are not continguous. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. Philips HS1 Trainer, Philips, Guidelines 2005 M5085A $469.00. However, if the user is not in the Preservation Registry and fails to return his or her unit, then Philips may charge the users DME supplier for the cost of the replacement device. No. Does this issue affect other Philips defibrillator products? In April 2022 Philips notified customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs. In the event of significant loss of gel, there is a possibility that the pad may not adhere correctly, or not make effective contact with a patients skin. This Recall for Product Correction is intended to inform you about: what the problem is and under what circumstances it can occur Lift out the used SMART pads cartridge. In some cases, this foam showed signs of degradation (damage) and chemical emissions. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). Does this issue affect other Philips defibrillator products? The notification advises customers that some affected pads may exhibit the gel separation issue. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. Should they stop using the devices? You can view a short video showing how to replace the pads cartridge at the following web address. Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). Please make a note of the Serial Number(s) of your HS1/OnSite/Home AED(s) and contact Philips or your local Philips Representative who will be able to tell you to whom the notification was sent. This is a voluntary Type II recall with Health Canada. At the time, Philips Respironics could not exclude possible carcinogenic effects with the limited dataset that was available. 1. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. This also includes an in-depth review and re-assessment of data and toxicological risk-assessments prior to June 2021. Any HS1/OnSite/Home AED pad (PN:M5071A, M5072A) currently installed in or stored with an HS1/OnSite/HomeAED could experience this issue. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Please read the document provided by Philips in regards to the above recall for detailed description and steps to follow. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. To learn more, click here. We thank you for your patience as we work to restore your trust. Philips has issued notifications to customers of approximately 1 million HeartStart HS1, OnSite, and Home Automated External Defibrillators (AEDs), which are supplied with a total of 1.8 million SMART Pads Cartridges. Philips m5071a: HeartStart OnSite AED Pads | AED Market It is not possible to know prior to patient use if a pad is affected because the pads are protected by a foil seal. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. This is a potential risk to health. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owners Manual and the Urgent Medical Device Correction Letter/Field Safety Notice. 2. U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit. Using packing tape supplied, close your box, and seal it. As described in the Instructions For Use (IFU), it is recommended that you store a spare pads cartridge with your HS1/OnSite/Home AED. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. An Official Philips AED web-store.