BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2946196 · Received January 3, 2013

    Report

    Report Number
    2031702-2013-00330
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE PARAMEDIC REPORTED THAT THE PATIENT WAS COMATOSE FOR TRANSPORT. THE VENTILATOR SOUNDED AS THOUGH IT WAS NOT DELIVERING ANY AIR TO THE PATIENT. BY THE TIME THE PARAMEDIC PREPARED THE MANUAL VENTILATION BAG, THE VENTILATOR WAS OPERATING NORMALLY. THIS HAPPENED ABOUT FOUR TIMES AND THE PATIENT REMAINED ON THE VENTILATOR THROUGHOUT THE TRANSPORT. NO PATIENT HARM REPORTED AND THERE WERE NO VENTILATOR ALARMS ACTIVATED AT ANY TIME. THE PATIENT'S OXYGEN SATURATION REMAINED ABOVE 90% THROUGHOUT THE TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4141 LTV VENTILATOR, CONTINUOUS/ CBK CBK CAREFUSION 203, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI