MAUDE Adverse Event Report: RESMED PTY LTD AIRSENSE 10 AUTOSET USA CO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	37207
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	11/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
An investigation will be performed on all available information based on reporter's obligations under applicable fda regulations; however, it is likely that this matter may become the subject of litigation which may limit the company¿s ability to disclose confidential, privileged attorney client communications and work product.Investigation methods, results and conclusions are not finalized at this stage because the device in question has not been returned to resmed for inspection.If more information becomes available, a supplemental report will be submitted.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that a patient was hospitalized and subsequently expired on (b)(6), 2022 due to esophageal cancer.It was reported that the patient had been using an airsense 10 autoset device for a few years leading up to his death.It was reported that the patient used a uv cleaner to clean their device.It was alleged that resmed device may have contributed to the patient¿s death based on the information out there about the philips devices.There was no allegation of a specific device malfunction.

• Brand Name: AIRSENSE 10 AUTOSET USA CO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 19315551
• Report Number: 3007573469-2024-00140
• Device Sequence Number: 17878225
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1272938
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 05/14/2024
• Report Date (Section F): 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 37207
• Device Catalogue Number: 37207
• Device Lot Number: 1272938
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2024
• Device Age: 77 MO
• Date Report to Manufacturer: 05/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2017
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male
• Date Report Sent to FDA: 05/14/2024