MAUDE Adverse Event Report: RESMED PTY LTD AIRFIT F30 MED SYS - EU; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 64111

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/02/2024

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 not been returned to resmed.Photos of the mask provided to resmed revealed that the anti-asphyxia valve flap had detached from the mask elbow.The investigation methods, results and conclusion are not finalized at this stage.If more information is available, a supplemental report will be submitted.The airfit f30 user guide provides the following warning: - ¿ always follow cleaning instructions.Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapors.¿ visual criteria for product inspection: if there is any visible deterioration of a mask component (cracking, crazing, tears etc.), the component should be discarded and replaced.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient experienced "sensation" of choking and suffocation allegedly due to inhaling part of an airfit f30 full face mask valve that came loose during mask usage while asleep.The patient was awakened due to this incident and managed to expel the loose part.

Manufacturer Narrative

The mask and dislodged anti asphyxia valve (aav) were returned to resmed for an investigation.Visual inspection of the returned elbow confirmed a missing aav on one side and revealed no physical tearing of the dislodged aav.Visual inspection under a microscope revealed unexpected dents on the slots of the elbow assembly where the aav sits.In addition, there were patches of missing material on the ends of the dislodged aav suggesting forces acting on it.Based on all available evidence, the investigation determined that the reported complaint was due to physical abuse.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient experienced "sensation" of choking and suffocation allegedly due to inhaling part of an airfit f30 full face mask valve that came loose during mask usage while asleep.The patient was awakened due to this incident and managed to expel the loose part.

• Brand Name: AIRFIT F30 MED SYS - EU
• 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: 18804828
• MDR Text Key: 336509494
• Report Number: 3007573469-2024-00049
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 64111
• Device Catalogue Number: 64111
• Device Lot Number: 1659394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2024
• Distributor Facility Aware Date: 04/23/2024
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 04/25/2024
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 80 KG