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 Problems Headache (1880); Memory Loss/Impairment (1958)

Event Date 03/15/2023

Event Type  Injury  

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 the following warnings: - ¿do not use the mask if the valve or vent assembly is damaged or missing.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.Discontinue using this mask if you have any adverse reaction to the use of the mask, and consult your physician or sleep therapist.As with all masks, some rebreathing may occur at low cpap pressures.¿ resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).Medwatch reference: mw5147711.

Event Description

It was reported to resmed that a patient using an airfit f20 mask experienced headache and memory loss allegedly due to rubber valves of the mask staying sealed.The patient stated the mask valve remains sealed which causes them to inhale "exhaled air".It was reported the patient then "cut out one of the rubber valves" from the elbow, felt better except brain function and memory, and continued using the mask.The patient consulted his doctor who did not provide medical treatment to the patient for his symptoms.

• 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
• 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: 18500105
• MDR Text Key: 332721944
• Report Number: 3004604967-2024-00012
• 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
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63402
• Device Catalogue Number: 63402
• Device Lot Number: 63402
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/14/2023
• Date Manufacturer Received: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male