MAUDE Adverse Event Report: RESMED PTY LTD AIRCURVE 10 VAUTO USA CO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	37211
Medical Device Problem Codes	Fire (1245); Device Emits Odor (1425); Decrease in Pressure (1490)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the device by a third-party service center identified an issue with the device motor in which the motor was replaced.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 conclusion are not finalized at this stage.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that a patient developed a first-degree burn on their right facial cheek, accompanied by irritation, swelling, discharge of a white substance, and peeling allegedly from use of an unspecified mask and aircurve 10 vauto device.The patient reported difficulty eating and sleeping due to their reported symptoms.The patient alleged the device was emitting a burning smell and the air did not feel like it was blowing properly.The patient sought medical treatment at a hospital and received a prescription.There was no report of visible flame observed from the device or external damage of the device.On january 15, 2026, resmed was informed that the device allegedly caught fire.

• Brand Name: AIRCURVE 10 VAUTO 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: 24448887
• Report Number: 3004604967-2026-01100
• Device Sequence Number: 10220793
• Product Code: BZD
• UDI-Device Identifier: 00619498372119
• UDI-Public: (01)00619498372119(10)1812928
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K160822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 37211
• Device Catalogue Number: 37211
• Device Lot Number: 1812928
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female