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
The device was returned to resmed for an engineering investigation.The investigation methods, results and conclusion are not finalized at this stage.When more information is available, a supplemental report will be submitted.(b)(4).Pending evaluation.
Event or Problem Description
It was allegedly reported to resmed that an airsense 10 device caught fire.There was no patient harm or a serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The airsense 10 autoset device was returned to resmed for an investigation.Visual inspection revealed water ingress and damage to the device, oxidation of the power inlet.The investigation determined that the reported event was due to water damage.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: pr (b)(4).
Event or Problem Description
It was allegedly reported to resmed that an airsense 10 device caught fire.There was no patient harm or a serious 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: 9729992
• Report Number: 3007573469-2020-00259
• Device Sequence Number: 11593209
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1247647
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 08/04/2020
• Report Date (Section F): 08/04/2020

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: 37208
• Device Catalogue Number: 37208
• Device Lot Number: 1247647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/14/2020
• Device Age: 30 MO
• Event Location: Home
• Date Report to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 113
• Date Report Sent to FDA: 08/04/2020