BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTILATOR, CONTINUOUS MINIMAL VENTILATORY SUPPORT FACILITY.

    MDR report key: 2472000 · Received February 23, 2012

    Report

    Report Number
    2518422-2012-00066
    Event Type
    Death
    Date Received
    February 23, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    MNT
    PMA / PMN Number
    K982454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A PT WHO WAS CONNECTED TO A BIPAP VISION EXPIRED WHILE BEING TRANSPORTED TO AN INTENSIVE CARE UNIT (ICU). ACCORDING TO THE REPORTER OF THE EVENT, THE PT'S MEDICAL CONDITION WAS DETERIORATING AND SHE WAS TO BE TRANSFERRED TO THE ICU. A CAREGIVER UNPLUGGED THE BIPAP VISION FROM THE AC POWER SOURCE AND DISCONNECTED THE DEVICE FROM THE 50 PSI OXYGEN SOURCE. THE MASK AND TUBING WHICH WERE BEING USED IN CONJUNCTION WITH THE BIPAP VISION, WERE STILL ATTACHED TO THE PT DURING THE TRANSPORT. THE BIPAP VISION WAS REPORTED TO HAVE BEEN AUDIBLY ALARMING THROUGHOUT THE TRANSPORT. THE PT EXPIRED IN THE ICU. THE BIPAP VISION IS NOT INTENDED FOR LIFE SUPPORT AND IS NOT DESIGNED TO BE USED AS A TRANSPORT VENTILATOR. THE DEVICE DOES NOT HAVE AN INTERNAL OR EXTERNAL BATTERY SOURCE TO OPERATE IN THE ABSENCE OF AC POWER. WHEN THE BIPAP VISION WAS UNPLUGGED FROM THE AC POWER SOURCE, IT NO LONGER WAS PROVIDING THERAPY TO THE PT. THE DEVICE BEGAN AUDIBLY ALARMING TO ALERT THE CAREGIVER OF THE EVENT THE REPORTING FACILITY CONFIRMED THE NURSING STAFF HAS BEEN RE-EDUCATED ON THE BIPAP VISION AND ITS INTENDED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS MINIMAL VENTILATORY SUPPORT FACILITY. BIPAP VISION MNT RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 582059

    Patients

    Seq Age Sex Outcome Treatment
    1 Death