MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADVANCED SYSTEM ONE 60 SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DS960S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was contacted in reference to an information request concerning disposing of a device.The manufacturer was informed that the patient was deceased.There is no allegation of device malfunction.There is no allegation that the device contributed to the patient death.No other information is available at this time.This report is being submitted for an allegation of a patient death only due to insufficient information related to the device.The device has not been returned to the manufacturer for investigation.The manufacturer investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP AUTOSV ADVANCED SYSTEM ONE 60 SERIES
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21613602
• Report Number: 2518422-2025-103067
• Device Sequence Number: 7554207
• Product Code: MNS
• UDI-Device Identifier: 00606959012516
• UDI-Public: (01)00606959012516
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: DS960S
• Device Catalogue Number: DS960S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 03/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown