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

Model Number	37207
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
It was reported to resmed that an airsense 10 autoset had a pressure issue and the patient experienced a lack of air, developed heart attack-like symptoms and was taken to the hospital.It was reported the patient recovered.
Additional Manufacturer Narrative
The astral device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.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 autoset had a pressure issue and the patient experienced a lack of air, developed heart attack-like symptoms and was taken to the hospital.It was reported the patient recovered.

• 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: 9522335
• Report Number: 3004604967-2019-00486
• Device Sequence Number: 2703733
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1399441
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/04/2020

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?: No
• 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: 12/11/2019
• Distributor Facility Aware Date: 05/13/2020
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1