MAUDE Adverse Event Report: RESMED PTY LTD AIRSENSE 11 AUTOSET USA CO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	39000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
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.Resmed reference#: case (b)(4).
Event or Problem Description
It was reported to resmed that an airsense 11 device allegedly caught fire.The device was plugged into a wall outlet, not in use at the time, and no audible or visual alarms were noted.It was reported that the fire resulted melting of the device on the left side, tubing, power supply unit, mask (which fused to the tubing), and damage to the nightstand and surrounding area.No injuries or requirement for medical treatment was reported.It was reported that the fire department was not contacted as the fire was contained immediately.

• Brand Name: AIRSENSE 11 AUTOSET USA CO
• Common Device Name: 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: 24947471
• Report Number: 3004604967-2026-01161
• Device Sequence Number: 10315530
• Product Code: BZD
• UDI-Device Identifier: 00619498390007
• UDI-Public: (01)00619498390007(10)1926862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 39000
• Device Catalogue Number: 39000
• Device Lot Number: 1926862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male