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

Model Number	37207
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
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.Resmed reference#: (b)(4).
Event or Problem Description
It was allegedly reported to resmed that an airsense 10 power supply caught fire.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: AIRSENSE 10 AUTOSET USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11585981
• Report Number: 3004604967-2021-00444
• Device Sequence Number: 14224454
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1460177
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/29/2021

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: 37207
• Device Catalogue Number: 37207
• Device Lot Number: 1460177
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 86