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

Model Number	37207
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received by resmed without the power cord.An evaluation was performed, however, since incomplete device was returned, resmed is unable to confirm the alleged malfunction at this time.The customer was provided a replacement device.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that the power cord of an airsense 10 device caught fire.The device was not in patient use when the reported event occurred.There was no patient harm or a serious injury reported as a result of this incident.
Event or Problem Description
It was reported to resmed that the power cord of an airsense 10 device caught fire.The device was not in patient use when the reported event occurred.There was no patient harm or a serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The device was received by resmed and an evaluation was performed.The reported complaint could not be confirmed during evaluation.An investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• 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: 10588039
• Report Number: 3004604967-2020-00929
• Device Sequence Number: 16842506
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1343307
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/24/2020

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: 1343307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Distributor Facility Aware Date: 11/02/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 123