MAUDE Adverse Event Report: ResMed Pty Ltd AirSense 10 AutoSet USA TRI; Ventilator, non-continuous (respirator)

Model Number	37208
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that a patient¿s airsense 10 device allegedly caught fire while the patient was away at work.It was reported that the smoke alarm in the patient's home was activated and that the fire department were called.According to the patient, the fire allegedly originated from the device and spread to nearby curtains and a dresser, resulting in property damage.No personal injuries were reported.
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.If further information becomes available, a supplemental report will be submitted.Resmed reference#: (b)(4).

• Brand Name: AirSense 10 AutoSet USA TRI
• Common Device Name: Ventilator, non-continuous (respirator)
• Manufacturer (Section D): ResMed Pty Ltd; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 50863104
• Report Number: 3007573469-2026-01379
• Device Sequence Number: 10673809
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1709840
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026
• Report Date (Section F): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 37208
• Device Catalogue Number: 37208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2026
• Device Age: 38 MO
• Event Location: Home
• Date Report to Manufacturer: 09/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/23/2026