BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 4906695 · Received July 10, 2015

    Report

    Report Number
    2031702-2015-00131
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    May 1, 2015
    Report Date
    July 10, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM THAT THE UNIT WOULD NOT ALARM. THE VENTILATOR FAILED THE PATIENT ASSIST PORT TEST FROM LTV SERVICE FINAL TEST. THE VENTILATOR IS CONSTANTLY ALARMING ¿ON¿ UNDER ANY CONDITION USING NURSE CALL TEST FIXTURE. BENCH TESTING REVEALED COMPONENT Q44 ON POWER BOARD HAD BECOME SHORTED FROM PIN 1 TO PIN 2. THIS MALFUNCTION OF Q44 IS PREVENTING THE PATIENT ASSIST PORT RELAY FROM BEING SET TO THE ¿OFF¿ POSITION. THE POWER BOARD WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE VENTILATOR ALARMED, THE NURSE CALL WOULD NOT ALARM. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR WITH NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450505 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1