BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP VISION

    MDR report key: 1081365 · Received July 24, 2008

    Report

    Report Number
    2518422-2008-00020
    Event Type
    Death
    Date Received
    July 24, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 23, 2008
    Manufacturer
    RESPIRONICS INC.
    Product Code
    MNT
    PMA / PMN Number
    K982454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REVIEWED THEIR COMPLAINT DATABASE FOR SIMILAR COMPLAINTS AND HAVE NOT IDENTIFIED A TREND IN THE USE OF THE DEVICE IN AN OFF-LABEL MANNER. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) REPORT ALLEGING A BIPAP DEVICE WAS INVOLVED IN AN INCIDENT THAT RESULTED IN A PATIENT DEATH WAS RECEIVED BY THE MANUFACTURER. THE REPORT STATED A PATIENT WAS ADMITTED TO A HOSPITAL WITH BREATHING PROBLEMS AND WHAT WAS THOUGHT TO BE AN INFECTION (TYPE UNKNOWN). THE PATIENT'S CONDITION REPORTEDLY CONTINUED TO DETERIORATE AND SHE WAS PLACED ON THE BIPAP DEVICE DUE TO RESPIRATORY DISTRESS. ACCORDING TO INFORMATION CONTAINED IN THE MHRA REPORT, A GENERATOR TEST WAS CONDUCTED AT THE HOSPITAL WHILE THE PATIENT WAS ON THE BIPAP DEVICE. THE HOSPITAL GENERATOR TEST VERIFIES THE FUNCTIONALITY OF EMERGENCY POWER AC OUTLETS DURING A LOSS OF POWER; HOWEVER, THE BIPAP DEVICE WAS NOT PLUGGED INTO AN EMERGENCY POWER OUTLET DURING THE GENERATOR TEST. AS A RESULT, AC POWER TO THE BIPAP WAS LOST DURING THE GENERATOR TEST AND AS A RESULT THE DEVICE SHUT OFF, AND GENERATED A POWER LOSS ALARM TO ALERT THE CAREGIVERS OF THE EVENT. THE MHRA REPORT INDICATES THE PATIENT DID NOT RECEIVE ANY THERAPY FROM THE BIPAP DEVICE FOR A PERIOD OF TEN MINUTES AFTER THE GENERATOR TEST WAS INITIATED. UPON DISCOVERY THE DEVICE WAS WITHOUT POWER, THE PATIENT WAS REPORTEDLY PLACED ON ANOTHER DEVICE (TYPE UNKNOWN), BUT SUBSEQUENTLY EXPIRED. THROUGH INVESTIGATION AND REVIEW OF THE MHRA REPORT, THE MANUFACTURER DISCOVERED NO ALLEGATION THAT THE BIPAP DEVICE MALFUNCTIONED OR OPERATED IN AN UNEXPECTED MANNER. THE MHRA REPORT STATED THE DEVICE WAS EVALUATED BY THE HOSPITAL AND THEIR CONTRACTED SERVICE AGENT AND FOUND TO OPERATE AND ALARM AS DESIGNED. THE HOSPITAL ASSOCIATED WITH THE EVENT WAS CONTACTED REGARDING THE INTENDED USE OF THE BIPAP DEVICE AS A THERAPY DEVICE AND NOT FOR LIFE SUPPORT APPLICATIONS. THE HOSPITAL CONFIRMED THAT THEIR STAFF WERE AWARE THE DEVICE ASSOCIATED WITH THE EVENT WAS NOT INTENDED TO BE USED AS A LIFE SUPPORT DEVICE, OR ON PATIENTS WHO ARE NOT CAPABLE OF MAINTAINING SPONTANEOUS VENTILATION. THE CLINICAL MANUAL FOR THE BIPAP DEVICE (PART NUMBER 1009031, 12/04/01) STATES IT IS CONTRAINDICATED FOR PATIENTS THAT CANNOT MAINTAIN LIFE-SUSTAINING VENTILATION IN THE EVENT OF A BRIEF LOSS OF THERAPY. THIS PATIENT COULD NOT MAINTAIN ADEQUATE LIFE SUSTAINING VENTILATION WHEN THERAPY WAS LOST AND WAS THEREFORE, NOT WITHIN THE POPULATION INTENDED TO RECEIVE THERAPY FROM THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP VISION VENTILATOR, CONTINUOUS, MINIMAL SUPPORT MNT RESPIRONICS INC. 1001011

    Patients

    Seq Age Sex Outcome Treatment
    1 Death