BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 20332014 · Received September 30, 2024

    Report

    Report Number
    2518422-2024-59899
    Event Type
    Death
    Date Received
    September 30, 2024
    Date of Event
    June 8, 2023
    Report Date
    July 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959029798
    PMA / PMN Number
    K090539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY CONTACTED IN REFERENCE TO BIPAP AUTOSV ADV DEVICE. THERE WAS AN ALLEGATION OF PATIENT PASSING AWAY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE TECHNICIAN CONFIRMED THERE WAS NO FOAM PARTICLES IN THE AIR PATH DURING THE DEVICE EVALUATION. THE DEVICE PASSED ALL TESTS DURING THE EVALUATION. IN THIS REPORT, BOX B, D, G, H HAS BEEN UPDATED/CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO BIPAP AUTOSV ADV DEVICE. THERE WAS AN ALLEGATION OF PATIENT PASSING AWAY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962589 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DS960XHS 00606959029798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death