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

Model Number	37208
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to resmed for an evaluation.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 to resmed that an airsense 10 device was involved in a house fire.The device was not in patient use when the reported event occurred.
Event or Problem Description
It was reported to resmed that an airsense 10 device was involved in a house fire.The device was not in patient use when the reported event occurred.
Additional Manufacturer Narrative
The astral device was not returned to resmed.An investigation was performed on all available information.Based on the available information, there is no conclusive evidence at this time to indicate whether the airsense 10 device or usb hub caused the fire.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: AIRSENSE 10 AUTOSET USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12862879
• Report Number: 3004604967-2021-01179
• Device Sequence Number: 11216833
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1277665
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 1277665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/18/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 04/14/2022
• Date Device Manufactured: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female