BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP VISION

    MDR report key: 2822550 · Received September 27, 2012

    Report

    Report Number
    2822550
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    August 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ON BIPAP IN THE EMERGENCY ROOM THEN TRANSFERRED TO NURSING UNIT ON VENTI-MASK. ONCE IN PATIENT ROOM BIPAP WAS SET UP AND THE PATIENT WAS PLACED ON IT. THE BIPAP THEN STARTED TO ALARM O2 FLOW, AND THE PATIENT'S O2 SATS DECREASED TO 83%. THE O2 CONNECTOR WAS SWITCHED TO OTHER O2 OUTLET, AND THE ALARM STOPPED, AND THE PATIENT'S O2 SATS ROSE TO 92%. THIRTY MINUTES LATER THE BIPAP BEGAN TO ALARM AGAIN WITH O2 FLOW, AND THE PATIENT'S SATS DECREASED TO 80%. AT THAT TIME, THE PATIENT WAS TAKEN OFF BIPAP AND PLACED ON 100% NON-REBREATHER UNTIL A NEW BIPAP MACHINE WAS RECEIVED. THE PATIENT WAS THEN PLACED ON A NEW BIPAP MACHINE AND THE O2 SATS INCREASED TO 100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP VISION NONINVASIVE VENTILATORY SUPPORT SYSTEM DQA PHILIPS HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR