BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4016104 · Received August 1, 2014

    Report

    Report Number
    4016104
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 1, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREMATURE INFANT IN NICU BEING SUPPORTED WITH CAREFUSION 3100A NEONATAL HIGH-FREQUENCY OSCILLATORY VENTILATOR. RESPIRATORY THERAPIST CALLED TO BEDSIDE BECAUSE THE CAREFUSION 3100A FAILED TO CYCLE. OSCILLATIONS STOPPED. PISTON WAS MAKING A SKIPPING NOISE. CAREFUSION 3100A RESTARTED, FUNCTIONED FOR A MINUTE, THEN MADE DIFFERENT NOISES AND STOPPED AGAIN. CAREFUSION 3100A WOULD NOT STAY ON. THE PATIENT WAS TAKEN OFF THE CAREFUSION 3100A. PATIENT SUPPORTED BY RESPIRATORY THERAPIST UNTIL SUBSTITUTED WITH ANOTHER VENTILATOR. NO UNTOWARD PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450375 * VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO