MAUDE Adverse Event Report: RESMED PTY LTD AIRCURVE 10 VAUTO USA TRI; Ventilator, Non-Continuous (Respirator)

Model Number	37212
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Codes	Anxiety (2328); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that a patient's aircurve 10 device allegedly overheated and caught fire on (b)(6) 2024, igniting the mattress and bedding while the patient was asleep.The patient stated they had been using the device for approximately three hours and had filled the water tank prior to use.The fire was contained to the bedroom, with smoke damage reported throughout the home.The patient reported psychological distress (ptsd and anxiety) following the incident.
Additional Manufacturer Narrative
An investigation will be performed on all available information based on reporter's obligations under applicable fda regulations; however, it is likely that this matter may become the subject of litigation which may limit the company's ability to disclose confidential, privileged attorney client communications and work product.Investigation methods, results and conclusions are not finalized at this stage partly because the device in question has not been returned for inspection.Resmed has requested the device be returned so that an investigation can be performed.Resmed reference#: (b)(4).

• Brand Name: AIRCURVE 10 VAUTO USA TRI
• Common Device Name: Ventilator, Non-Continuous (Respirator)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, 2153 ; AS 2153
• MDR Report Key: 23433482
• Report Number: 3004604967-2025-00388
• Device Sequence Number: 4783099
• Product Code: BZD
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K140159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2026

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: 37212
• Device Catalogue Number: 37212
• Device Lot Number: 1702917
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown