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
Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not 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 device caught fire.There was no patient harm or a serious injury reported as result of this incident.
Additional Manufacturer Narrative
This report is being submitted as a correction to the initial report.It was determined on march 12, 2020 that two medwatch reports were submitted for the same event associated with device airsense 10, serial number (b)(4).Complaint was initially recorded in resmed ref: (b)(4) with an aware date of jan 9, 2020.The complaint was deemed reportable and a medwatch report was filed, manufacturer report number: 3004604967-2020-00219.Resmed ref: (b)(4) was created on jan 20, 2020 to process the device return.The complaint was deemed reportable and a medwatch report was filed, manufacturer report number: 3004604967-2020-00259.Therefore, two complaints were created and reported as medwatches for the same issue.The initial medwatch report 004604967-2020-00219 was deemed as a duplicate and this supplemental report is being submitted as a correction.Please refer to report number 3004604967-2020-00259 for a detailed investigation regarding the reported event.
Event or Problem Description
It was reported to resmed that an airsense 10 device caught fire.There was no patient harm or a serious injury reported as 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: 9673950
• Report Number: 3007573469-2020-00219
• Device Sequence Number: 16743282
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1247647
• Combination Product (Y/N): N
• 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): 04/06/2020
• Report Date (Section F): 04/06/2020

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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/12/2020
• Device Age: 30 MO
• Event Location: Home
• Date Report to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: 04/06/2020