MAUDE Adverse Event Report: RESMED LTD AIRFIT F20 LGE - AMER

Model Number 63402

Device Problems Break (1069); Device Slipped (1584); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 04/25/2021

Event Type  Death  

Manufacturer Narrative

Resmed has requested return of the device so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an airfit20 full face mask was making a strange noise, the magnet clip of the mask had broke and the mask slipped off of the patient's face.Subsequently, the patient expired.

Manufacturer Narrative

Resmed has requested return of the device so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an airfit20 full face mask was making a strange noise, the magnet clip of the mask had broke and the mask slipped off of the patient's face.Subsequently, the patient expired.

• Brand Name: AIRFIT F20 LGE - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11898691
• MDR Text Key: 253108421
• Report Number: 3007573469-2021-00640
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63402
• Device Catalogue Number: 63402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2021
• Distributor Facility Aware Date: 08/04/2021
• Date Report to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 53 YR