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

Model Number	37208
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the reporter, the "patient smelled a burning smell at around 5 pm and went in to the bedroom and noticed a fire on the carpet due to what he believed came from the device." also, according to the reporter, the vpap was attached to oxygen but the vpap was not on.Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not yet been returned, therefore resmed is unable to confirm the alleged malfunction at this time.(b)(4).
Event or Problem Description
It was reported to resmed that an airsense 10 autoset usa tri vpap was allegedly involved in a fire.The device was not is use and not turned on at the time of the event, therefore, there was no patient injury reported as a result of this incident.
Additional Manufacturer Narrative
The device was returned to resmed for an investigation.Visual inspection of the device revealed thermal damage to the device.The investigation determined the thermal damage to the device was caused by an external heat source.There was no fault found with the returned device.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).
Event or Problem Description
It was reported to resmed that an airsense 10 autoset usa tri vpap was allegedly involved in a fire.The device was not is use and not turned on at the time of the event, therefore, there was no patient injury reported as a result of this incident.

• Brand Name: AIRSENSE 10 AUTOSET USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 6980582
• Report Number: 3004604967-2017-01497
• Device Sequence Number: 944000
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1233328
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K140124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 37208
• Device Catalogue Number: 37208
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/04/2018
• Device Age: 5 MO
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1