BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3250617 · Received July 26, 2013

    Report

    Report Number
    2031702-2013-00161
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 26, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD NO AIR FLOW FROM THE TURBINE DURING A BENCH TEST. THE TECH COULD HEAR HIGH PITCHED WHINING NOISE. THIS PROBLEM WAS NEVER REPORTED BY THE USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350453 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1