BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP AVAPS CSERIES

    MDR report key: 12009571 · Received June 16, 2021

    Report

    Report Number
    2518422-2021-01718
    Event Type
    Death
    Date Received
    June 16, 2021
    Date of Event
    June 11, 2021
    Report Date
    June 16, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    MNS
    UDI-DI
    00606959015777
    PMA / PMN Number
    K102465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP AVAPS CSERIES DEVICE WAS NOT OPERATING PROPERLY AND THE PATIENT EXPIRED. THE REPORTER OF THE EVENT CONFIRMS THE PATIENT'S FAMILY IS NOT RELEASING THE DEVICE. THE DEVICE IS NOT RETURNING FOR EVALUATION. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903843 BIPAP AVAPS CSERIES VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS PHILIPS RESPIRONICS INC. CN1167HS 00606959015777

    Patients

    Seq Age Sex Outcome Treatment
    1 Death