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

Model Number	37207
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to resmed for an engineering investigation.Initial visual inspection of the device revealed evidence of insect infestation, burnt power cord and damaged power supply unit 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 allegedly reported to resmed that a power supply unit of an airsense 10 autoset caught fire.There was no patient harm or serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The airsense 10 autoset device was returned to resmed for an investigation.Visual inspection revealed evidence of insect infestation of the device, thermally damaged power cord and damaged power supply unit.The investigation determined the returned airsense 10 autoset device was performing to specifications.The investigation determined the reported complaint was due to the power cord.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
Event or Problem Description
It was allegedly reported to resmed that a power supply unit of an airsense 10 autoset 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: 12551556
• Report Number: 3007573469-2021-01012
• Device Sequence Number: 1204744
• Product Code: CBK
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1318216
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022
• Report Date (Section F): 02/23/2022

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: 37207
• Device Catalogue Number: 37207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/14/2022
• Device Age: 37 MO
• Date Report to Manufacturer: 02/23/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Date Report Sent to FDA: 02/23/2022