BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2843723 · Received October 29, 2012

    Report

    Report Number
    2843723
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    July 13, 2012
    Report Date
    October 29, 2012
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CIRCUITS THAT ATTACH THE INSPIRATORY LIMB AT THE HEATER COME APART EASILY. THIS RESULTS IN A LEAKING CONNECTION THAT PREVENTS THE OSCILLATOR FROM CALIBRATING. WHILE TROUBLESHOOTING THE CALIBRATION PROBLEMS IT WAS DISCOVERED THAT SOME DIAPHRAGM CAPS ARE NOT SEATED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TUBING, VENTILATOR, OSCILLATOR LSZ CAREFUSION 771465 0000411151
    2 * TUBING, VENTILATOR, OSCILLATOR LSZ CAREFUSION 771465 0000387562
    3 * TUBING, VENTILATOR, OSCILLATOR LSZ CAREFUSION 771465 000419147
    4 * TUBING, VENTILATOR, OSCILLATOR LSZ CAREFUSION 771465 0000437562
    5 * TUBING, VENTILATOR, OSCILLATOR LSZ CAREFUSION 771465 0000455519
    6 * TUBING, VENTILATOR, OSCILLATOR LSZ CAREFUSION 771465 0000464776

    Patients

    Seq Age Sex Outcome Treatment
    1 *