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

Model Number	37205
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2020
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 allegedly reported to resmed that an airsense 10 elite device caught fire.There was no patient harm or a serious injury reported as a result of this incident.
Event or Problem Description
It was allegedly reported to resmed that an airsense 10 elite device caught fire.There was no patient harm or a serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The astral device was returned to resmed for an investigation.Visual inspection revealed exterior fire damage to the device with no internal fire damage.The device was functional.The investigation determined the root cause is not related to device.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• Brand Name: AIRSENSE 10 ELITE USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11078001
• Report Number: 3007573469-2020-01261
• Device Sequence Number: 19648403
• Product Code: BZD
• UDI-Device Identifier: 00619498372058
• UDI-Public: (01)00619498372058(10)1335782
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/24/2021
• Report Date (Section F): 03/24/2021

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: 37205
• Device Catalogue Number: 37205
• Device Lot Number: 1335782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2021
• Device Age: 25 MO
• Event Location: Home
• Date Report to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 106
• Date Report Sent to FDA: 03/24/2021