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

Model Number 63468

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/30/2023

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the airfit f20 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 warning: - ¿if any visible deterioration of a system component is apparent (cracking, discoloration, tears etc.), the component should be discarded and replaced.¿ resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient using an airfit f20 mask with a stellar 150 device experienced oxygen desaturation and became unwell allegedly after noticing a tear in the cushion of the mask.The patient was hospitalized, has since been discharged and has continued therapy at home.It is not known how long the patient had been using the mask prior to the reported incident.There are no allegations against the stellar device.

• Brand Name: AIRFIT F20 CUSHION MED
• 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: 18251372
• MDR Text Key: 329555095
• Report Number: 3007573469-2023-00667
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498634064
• UDI-Public: (01)00619498634064(11)220831(10)1651198
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63468
• Device Catalogue Number: 63468
• Device Lot Number: 1651198
• 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: 12/01/2023
• Distributor Facility Aware Date: 11/08/2023
• Device Age: 14 MO
• Event Location: Home
• Date Report to Manufacturer: 12/01/2023
• Date Manufacturer Received: 11/08/2023
• Date Device Manufactured: 08/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female