MAUDE Adverse Event Report: RESMED PTY LTD AIRFIT F30 MED SYS - EU; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 64111

Device Problem Electromagnetic Interference (1194)

Patient Problems Red Eye(s) (2038); Blurred Vision (2137)

Event Date 10/15/2023

Event Type  Injury  

Event Description

It was reported to resmed that a patient using an airfit f30 mask and ocular implants experienced symptoms including red eyes, ocular irritation like grains of sand in the eyes and blurred side-vision.The patient reportedly had to squint to read.Further information about the type and materials of the implants and patient¿s medical condition is not available to resmed.

Manufacturer Narrative

Resmed requested the mask be returned so that an engineering investigation can be performed.In response to the request, resmed was informed the mask is not available to be returned to resmed for evaluation.On november 20, 2023, a field safety notice was issued by resmed (mwm-2023-fsn-01) for all lots of resmed masks with magnets: airfit n10, airfit n10 for her, airfit n20, airfit n20 for her, airtouch n20, airtouch n20 for her, airfit f20, airfit f20 for her, airfit f20 nv, airtouch f20, airtouch f20 for her, airfit f30, airfit f30i.Resmed has updated the contraindications and warnings in our mask with magnets¿ user guides so clinicians and patients aware of the potential risks associated with the magnetic fields and to take precautionary measures when using the mask.Corrective and preventative actions are being taken by resmed to resolve the issue.Mcapa-1637.Resmed reference#: (b)(4).

• Brand Name: AIRFIT F30 MED SYS - EU
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18809051
• MDR Text Key: 336576999
• Report Number: 3007573469-2024-00056
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 64111
• Device Catalogue Number: 64111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/29/2024
• Distributor Facility Aware Date: 01/30/2024
• Date Report to Manufacturer: 02/29/2024
• Date Manufacturer Received: 01/30/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female