BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3232967 · Received July 18, 2013

    Report

    Report Number
    2031702-2013-00155
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 17, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS ON THE VENTILATOR, THE LED'S BEGAN TO BLINK AND THE VENTILATOR SHUT DOWN WITH AUDIBLE/VISUAL ALARMS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS MANUALLY VENTILATED. THE CAREGIVER RE-STARTED THE VENTILATOR AND THEN PUT THE PATIENT BACK ON THE VENTILATOR. THIS HAPPENED 4 TO 5 TIMES, AFTER WHICH THE VENTILATOR WAS REPLACED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333782 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1