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

Model Number 63402

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

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.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.¿ the reportable event occurred outside the us.During a routine check of complaints records it was detected that the event is reportable in the us.This report is being submitted to correct the error.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that the "flaps" on the connector of an airfit f20 full face mask were allegedly getting stuck.It was reported that the patient needed to use excessive, forceful breathing to get them to move.There was no patient harm or a serious injury reported as a result of this incident.

• Brand Name: AIRFIT F20 LGE - 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: 18871243
• MDR Text Key: 337293337
• Report Number: 3007573469-2024-00063
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 63402
• Device Catalogue Number: 63402
• 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: 03/08/2024
• Distributor Facility Aware Date: 12/28/2023
• Date Report to Manufacturer: 03/08/2024
• Date Manufacturer Received: 12/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1