BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100B

    MDR report key: 2003930 · Received February 25, 2011

    Report

    Report Number
    2003930
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RT ATTEMPTED TO CHANGE INSPIRATORY TIME (IT) TO 50%. READJUSTED THE DELTA P BACK TO WHAT IT WAS SET AT 82, POWER AT 9. THE OSCILLATOR JUST STOPPED OSCILLATING. THE RT ATTEMPTED TO POWER IT BACK UP AND IT STOPPED AGAIN WITHIN A FEW SECONDS. THE PATIENT WAS TRANSFERRED TO A GE CARESTATION WITHOUT PROBLEMS. LOWEST SATURATION WAS 71%, HOWEVER PATIENT RECOVERED IMMEDIATELY WITH HAND VENTILATION. THE PATIENT WAS NOT HARMED. THIS IS THE FIRST TIME THIS VENTILATOR HAS EVER BEEN SERVICED. THE 3100B TURNED COMPLETELY OFF WHILE ON THE PATIENT AND LOST ELECTRICAL POWER. I AM NOT SURE WHAT, IF ANY, ALARMS WERE PRESENT. I BELIEVE JUST THE "POWER FAIL" ALARM. A THERAPIST WAS PRESENT WITH THE PATIENT AND IMMEDIATELY BAGGED THE PATIENT. DURING BENCH TESTING THE "OSCILLATOR OVERHEATED" LED WAS LIT. WE ALSO DUPLICATED THE POWER FAILURE DURING BENCH TESTING. THE MOVEMENT OF THE PISTON WAS NOTED TO BE ROUGH, WHEN THE OSCILLATOR ASSEMBLY WAS REMOVED FROM THE VENTILATOR.======================MANUFACTURER RESPONSE FOR OSCILLATOR 3100B, SENSOMEDICS======================WILL EVALUATE THE HIGH FREQUENCY OSCILLATORY VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3100B VENTILATOR, HIGH FREQUENCY, 3100B LSZ CAREFUSION 207, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR