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

Model Number 63403

Device Problem Obstruction of Flow (2423)

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

Event Date 01/31/2024

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 been disposed of and is not available to be returned to resmed.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).

Event Description

It was reported to resmed that the "exhalation valve" of an airfit f20 full face mask would not open and was stuck.The reported issue was observed during setup at home medical equipment provider site.There was no patient harm or a serious injury reported as a result of this incident.

• Brand Name: AIRFIT F20 FOR HER SML - 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
• 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: 18804883
• MDR Text Key: 336761574
• Report Number: 3004604967-2024-00051
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 63403
• Device Catalogue Number: 63403
• Device Lot Number: 1716651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/31/2024
• Date Manufacturer Received: 01/31/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1