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

Model Number 63450

Device Problem Obstruction of Flow (2423)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported to resmed that the elbow flaps on an airfit f20 full face mask would not open or close.It was reported that the issue was discovered during set-up.There was no patient harm or a serious injury reported as a result of this incident.

Manufacturer Narrative

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 product was returned to resmed for an extensive engineering investigation.The investigation methods, results and conclusion are not finalized at this stage.If more information is available, a supplemental report will be submitted.Resmed reference#: (b)(4).Device received; evaluation pending.

• Brand Name: AIRFIT F20 STARTER PACK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18764742
• MDR Text Key: 336960877
• Report Number: 3004604967-2024-00045
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 63450
• Device Catalogue Number: 63450
• Device Lot Number: 1738573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/25/2024
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1