Field Safety Notice Philips Respironics Sleep and Respiratory Care (ICN 1819)
MHRA: 2022/008/015/596/001
NHS Supply Chain Reference: 48
Alert:
- Philips Respironics has issued a Field Safety Notice for five products:
- Amara View Minimal Contact Full-Face Mask
- DreamWear Full Face Mask
- DreamWisp Nasal Mask with Over the Nose Cushion
- Wisp Nasal Masks and Wisp Youth Nasal Masks
- Therapy Mask 3100 NC/SP.
- The supplier is updating its existing ‘Contraindications’ and ‘Warnings’.
- Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks that have implanted devices that may be affected by magnets.
- Magnets with a magnetic field strength of 400 mT are used in the mask, with the exception of the devices identified in the contraindication.
- Please ensure the mask is kept at least 6 inches (approx. 15.24 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.
Products Affected:
- There are 36 products are affected.
- See our Downloads section to access the product listing and Field Safety Notice for further information on the affected product codes.
Next Steps:
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Identify patients who have an implanted device where use of the magnetic mask is contraindicated and follow steps outlined in the Field Safety Notice.
- We will provide copies of the patient version of the Field Safety Notice and FAQs document to all patients using the affected devices.
- We will update this ICN with details of alternative products after clinical guidance has been completed.
- If you need any further information or support concerning this issue, please contact your local Philips Respironics representative: UK Philips Customer Care Service Centre on 0870 532 9741.
- If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Service Advisor.
UK Government Notification
https://www.gov.uk/drug-device-alerts/field-safety-notices-19-to-23-september-2022
US Food & Drug Agency – Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices