MAUDE Adverse Event Report: RESMED LTD AIRFIT F20 MED - AMER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 63401

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Choking (2464)

Event Type  malfunction  

Event Description

It was reported to resmed that a patient experienced suffocation and choking on several occasions allegedly due to the valves of an airfit f20 full face mask remaining closed.There was no serious injury reported as a result of this incident.

Manufacturer Narrative

Resmed has requested for the mask to be returned so that an engineering investigation can be performed.The mask has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.The airfit f20 user guide provides daily/after each use and weekly cleaning and maintenance instructions.The troubleshooting section also provides solutions for potential problems such as blocked or dirty vent, and wet vent.The user guide also provides the following warning: ¿if any visible deterioration of a system component is apparent (cracking, crazing, tears etc), the component should be discarded and replaced¿.It also warns to ¿discontinue using this mask if you have any adverse reaction to the use of the mask, and consult your physician or sleep therapist¿.Resmed includes the following statement in the airfit f20 user guide ¿the elbow, valve and vent assembly have specific safety functions.The mask should not be worn if the valve is damaged as it will not be able to perform its safety function.The elbow should be replaced if the valve is damaged, distorted or torn.The vent holes and valve should be kept clear.¿ resmed reference#: (b)(4).

• Brand Name: AIRFIT F20 MED - AMER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 16836158
• MDR Text Key: 314271713
• Report Number: 3007573469-2023-00326
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498640119
• UDI-Public: (01)00619498640119(11)220826(10)1647581
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 63401
• Device Catalogue Number: 63401
• Device Lot Number: (10)1647581
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2023
• Distributor Facility Aware Date: 03/30/2023
• Device Age: 7 MO
• Date Report to Manufacturer: 04/28/2023
• Date Manufacturer Received: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male