MAUDE Adverse Event Report: RESMED PTY LTD AIRFIT N20 SML SYS - AMER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 63503

Device Problem Electromagnetic Interference (1194)

Patient Problems Headache (1880); Dizziness (2194); Syncope/Fainting (4411)

Event Date 07/01/2023

Event Type  Injury  

Event Description

It was reported to resmed that an airfit n20 mask allegedly caused magnetic interference with a patient¿s ¿medtronic model shunt", causing the shunt to malfunction.Attempts were made to obtain additional information regarding the type of shunt used by the patient.No information has been received to date.The patient felt dizzy, was passing out and couldn¿t walk in straight line over the next 3 weeks.The patient also experienced pressure headaches.It was reported that the shunt kept switching settings and the patient had to undergo a revision surgery for the shunt.

Manufacturer Narrative

Resmed has requested for the mask to be returned so that an engineering investigation can be performed.The mask has been disposed of and therefore, 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 N20 SML SYS - AMER
• 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: 18557973
• MDR Text Key: 333439046
• Report Number: 3007573469-2024-00019
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63503
• Device Catalogue Number: 63503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2024
• Distributor Facility Aware Date: 12/23/2023
• Date Report to Manufacturer: 01/22/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: Z-0539-2024
• Patient Sequence Number: 1
• Patient Sex: Female