Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Royal Philips’ subsidiary Philips Respironics Certain Philips Respironics Masks for BiPAP, CPAP Machines [Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, Therapy Mask 3100 NC/SP] [HKMD No.: 150122, 130230].
According to the FDA, the manufacturer has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets and can potentially affect the functioning of or cause movement of certain implanted or attached metallic medical devices, which could result in injury or death. These potential adverse events can occur in people who use the masks, or in people near a person using the mask. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.
Medical devices that could potentially be affected by these magnets include brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators, ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants or any metallic implanted medical device affected by magnets.
For further information, please visit https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect;
https://www.fda.gov/news-events/press-announcements/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect;
The manufacturer advises that users of the above devices, if the implant/ medical device is contraindicated against the mask magnets, should stop using the device and consult their healthcare professionals. They should also keep the mask away from household members or carers who have the contraindicated implant/ device.
According to the Local Responsible Person (LRP), the affected device is distributed in Hong Kong. The LRP is following up the issue.
If you are in possession of the affected products, please contact the supplier for necessary actions:
Celki International Ltd.
Email: cs@airliquide.com
Telephone number: (852) 2268 9243
Posted on 9 Sep 2022