BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO I VENT

    MDR report key: 759729 · Received September 8, 2006

    Report

    Report Number
    MW1040386
    Event Type
    Injury
    Date Received
    September 8, 2006
    Date of Event
    September 6, 2006
    Report Date
    September 8, 2006
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING VENTILATED WITH A MARQUET SERVO I VENT, WHEN IT WAS OBSERVED THAT THE VENTILATOR APPEARED TO SPONTANEOUSLY SHUT DOWN AND RESTART. UPON REVIEW OF THE DATA, THE VENTILATOR MONITOR APPEARED TO HAVE SHUTDOWN AND RESTARTED WITHIN A 6 SECOND TIME PERIOD, RETAINING THE PATIENT SETTINGS. IT REMAINS UNCLEAR AS TO WHETHER THE VENTILATOR ITSELF STOPPED VENTILATING OR WHETHER IT WAS JUST THE CONTROLLER/MONITOR, HOWEVER, THE MONITOR SHOWS NO VENTILATION FOR THAT TIME PERIOD. THE DEVICE WAS IMMEDIATELY PULLED FROM SERVICE FOR EVALUATION. THERE WAS NO NEGATIVE PATIENT AFFECT FROM THE SHUTDOWN. THIS IS THE SECOND SUCH SHUTDOWN OBSERVED WITHIN A 4 MONTH PERIOD FOR THIS TYPE OF VENTILATOR -HAPPENED TO A DIFFERENT SERVO I VENT IN MAY. THE TWO VENTILATORS THAT FAILED HAD SEQUENTIAL SERIAL NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO I VENT SERVO I CBK MAQUET, INC. SERVO I VENTILATOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability