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

Model Number	37207
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 and an evaluation confirmed the complaint.The customer was provided a replacement device.When more information is available, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported to resmed that an airsense 10 device caught fire.There was no patient harm or an injury as a result of this incident.
Additional Manufacturer Narrative
The airsense 10 device was returned to resmed for an investigation.Visual inspection revealed evidence of high heat damage on the side panel, chassis and pneumatic motor block casing; no heat damage on the power supply unit plug or main circuit board.The investigation determined that the reported event was due to an external heat source.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that an airsense 10 device caught fire.There was no patient harm or an injury 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 ; AU 2153
• MDR Report Key: 9729993
• Report Number: 3004604967-2020-00260
• Device Sequence Number: 16876155
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1325658
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 37207
• Device Catalogue Number: 37207
• Device Lot Number: 1325658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Distributor Facility Aware Date: 04/29/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR