MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 AUTOSET USA CO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	37207
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that an airsense 10 device allegedly caught fire.The device was not in use on a patient at the time of the reported incident.
Additional Manufacturer Narrative
The astral device was returned to resmed.The investigation methods, results, and conclusions are not finalised at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that an airsense 10 device allegedly caught fire.The device was not in use on a patient at the time of the reported incident.
Additional Manufacturer Narrative
The airsense 10 device was returned to resmed for an investigation.Visual inspection of the device revealed the source of the thermal event was external to the device.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence, the investigation determined that the reported complaint was not related to the device.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• Brand Name: AIRSENSE 10 AUTOSET USA CO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 15712866
• Report Number: 3007573469-2022-00721
• Device Sequence Number: 12412416
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1297665
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023
• Report Date (Section F): 03/15/2023

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: 37207
• Device Catalogue Number: 37207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2023
• Device Age: 54 MO
• Event Location: Home
• Date Report to Manufacturer: 03/15/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/15/2023