MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 AUTOSET USA CO

Model Number	37207
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to resmed for an engineering investigation.Initial evaluation determined the device was performing to specifications.Visual inspection revealed thermal damage to the exterior of the device.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference#: (b)(4).
Event or Problem Description
It was reported that an airsense 10 device caught fire.It was reported the patient¿s son had a minor, small burn on neck due to debris; medical attention was not sought.The device was not in use at the time of the event.
Additional Manufacturer Narrative
The airsense 10 device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.Visual inspection of the power supply cord revealed damage and exposed cables.The investigation determined that the reported event was due to operator error.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
Event or Problem Description
It was reported that an airsense 10 device caught fire.It was reported the patient¿s son had a minor, small burn on neck due to debris; medical attention was not sought.The device was not in use at the time of the event.

• Brand Name: AIRSENSE 10 AUTOSET USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9814359
• Report Number: 3007573469-2020-00349
• Device Sequence Number: 1418025
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1403737
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 06/04/2020
• Report Date (Section F): 06/04/2020

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: 02/18/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2020
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/04/2020