BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2682453 · Received July 24, 2012

    Report

    Report Number
    2682453
    Event Type
    Malfunction
    Date Received
    July 24, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 29, 2012
    Manufacturer
    CAREFUSION 211, INC. DBA CAREFUSION
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR WAS BEING PREPARED TO BE USED ON A PATIENT, FAILED CALIBRATION DURING PRE USE CHECK. FAILED TO PRESSURIZE. RAN THROUGH A PRE USE CHECK ON THE HIGH FREQUENCY OSCILLATORY VENTILATOR MODEL 3100A AND THE VENTILATOR WOULD NOT CALIBRATE. TESTED 2ND VENTILATOR WITH THE SAME RESULTS. INVESTIGATED THE CIRCUIT AND REALIZED THAT THE CAP/DIAPHRAGM SET WAS DEFECTIVE. SAME ISSUES WITH OTHER LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CIRCUIT, SET, HIGH FREQUENCY OSCILLATOR BZO CAREFUSION 211, INC. DBA CAREFUSION 3100A 0000418490
    2 * CIRCUIT, HIGH FREQUENCY OSCILLATOR BZO CAREFUSION 211, INC, DBA CAREFUSION 3100A 0000413480
    3 * * --- * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 *
    2 *
    3 7 MO