BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP VISION

    MDR report key: 2800919 · Received September 20, 2012

    Report

    Report Number
    2800919
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    September 8, 2012
    Report Date
    September 20, 2012
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    STAFF HEARD BIPAP ALARMING, WENT INTO ROOM AND THE BIPAP SCREEN WAS BLACK AND THE WRENCH WAS LIT UP. THE PATIENT WAS PLACED ON NASAL CANNULA UNTIL A NEW MACHINE WAS BROUGHT TO ROOM, AND WAS UTILIZED WITHOUT ISSUE. THIS IS A RENTAL BIPAP VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP VISION VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY MNT PHILIPS RESPIRONICS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR