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

Model Number 63401

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Dyspnea (1816)

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.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#: pr (b)(4).Medwatch reference# mw5100609.

Event Description

It was reported to resmed that a patient could not restfully breathe and experienced difficulty breathing and stale air buildup allegedly due to visible black substance embedded in the filter mesh of a quietair elbow of an airfit f20 mask.There was no harm or serious injury reported as a result of this incident.

• Brand Name: AIRFIT F20 MED - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11891249
• MDR Text Key: 255939677
• Report Number: 3004604967-2021-00637
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K161978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1