BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO BIPAP

    MDR report key: 16515613 · Received March 9, 2023

    Report

    Report Number
    MW5115627
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 7, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959022546
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY PHILIPS, RESPIRONICS INC BIPAP DEVICE WAS RECALLED IN 2021. PHILIPS NOTIFIED ME 5 MONTHS AGO THAT MY REPLACEMENT WAS READY TO BE SHIPPED. THE REPLACEMENT IS NEVER SHIPPED. I HAVE REPEATEDLY CALLED PHILIPS AND CONSISTENTLY AM TOLD THAT THE REPLACEMENT IS IN SHIPPING AND I WOULD BE CONTACTED. THIS NEVER HAPPENS. I AM WITHOUT A REPLACEMENT DEVICE WITH NO RECOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593044 AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX700T11 00606959022546

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male BIPAP | D3| ROSUVASTATIN