MAUDE Adverse Event Report: RESMED LTD AIRSENSE 11 AUTOSET USA TRI

Model Number	39001
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that an airsense 11 power cord caught fire.There was no patient harm or a serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The device was returned to resmed for an engineering investigation.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).Pending evaluation.
Additional Manufacturer Narrative
The airsense 11 device and power cord were returned to resmed for an investigation.Visual inspection revealed pinch points on the ac power cord, rough patches on the jacket of the ac power cord and no burn marks on the device or power supply unit.The device and power supply unit were performing to specifications with a known good ac power cord.Based on all available evidence, the investigation determined that the reported complaint was due to physical abuse.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).
Event or Problem Description
It was reported to resmed that an airsense 11 power cord caught fire.There was no patient harm or a serious injury reported as a result of this incident.

• Brand Name: AIRSENSE 11 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: 12912717
• Report Number: 3004604967-2021-01192
• Device Sequence Number: 11274408
• Product Code: BZD
• UDI-Device Identifier: 00619498390014
• UDI-Public: (01)00619498390014(10)1563611
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K203126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 39001
• Device Catalogue Number: 39001
• Device Lot Number: 1563611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 02/27/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 130 KG