Philips Respironics Recalls Additional BPAP Devices
Philips Respironics has alerted the FDA regarding two additional issues over the last month.
- On Aug. 29, the FDA issued a safety communication concerning a limited recall by Philips of approximately 400 bi-level positive airway pressure (BPAP; A-Series BiPAP A30, A40, V30 and Omnilab Advanced+) devices that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals called volatile organic compounds, which could result in symptoms of headache, dizziness, irritation to the eyes, nose, and respiratory tract; nausea, and toxic and cancer-causing effects. The plastic may also cause the machine to fail and stop working suddenly during use. To date, the FDA is not aware of any reports of serious injury associated with this recall. This recall is separate from another Philips recall initiated in June 2021 regarding PE-PUR foam in CPAP and BPAP units. For more information, please read the FDA advisory.
- Philips also alerted the FDA on Sept. 6 regarding an update on instructions related to using magnetic headgear clips on masks used for the delivery of airway pressure (Amara View full face mask, Dreamwisp nasal mask, Wisp and Wisp Youth Nasal mask, Therapy mask 3100 NC/SP) that could result in potential risk of injury. These particular masks could potentially result in injury or death by interfering with the normal functioning of certain implanted metallic medical devices (such as a pacemaker, implantable defibrillator, neurostimulators, cerebral spinal fluid shunts) or metallic objects in the body. The risk of injury is not only for individuals who use these masks, but also for people near a person using the recalled masks.
A comprehensive list of contraindicated metallic devices can be found in the FDA safety announcement. Philips reported to the FDA that, as of September 2022, there were 16 serious injuries where the mask magnets may have affected implanted metallic medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartrate, and cognitive issues.
Current recommendations are to inform patients that have the listed implanted medical devices to stop the use of the mask with magnets and replace with an alternative mask. As a precaution, the magnetic mask should be kept more than six inches away from any person that has an implanted medical device.
ATS members may also be aware that other manufacturers (for example, Resmed, Ltd) make PAP masks with magnetic clips. Safety recommendations have been previously issued on the dispensing of these masks for patients with active medical implants, such as pacemakers or implantable defibrillators, and are recommended to be kept away from implants to avoid any potential interference. The magnetic clips are also not suitable for use in cases where patients have a metallic hemostatic clip implanted in the head to repair an aneurysm, or a metallic splinter in one or both eyes.
The FDA has asked that if you are aware of any adverse events experienced with the use of masks containing magnetic clips should be reported to the FDA’s MedWatch Program or by phone at 1-800-FDA-1088. You can also call 1-800-322-1088 for more information on how to mail or fax the form.
