BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO I

    MDR report key: 787383 · Received November 21, 2006

    Report

    Report Number
    787383
    Event Type
    Injury
    Date Received
    November 21, 2006
    Date of Event
    November 19, 2006
    Report Date
    November 21, 2006
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SERVO I VENTILATOR DISPLAY SCREEN WAS FLASHING ERRATICALLY. USER WAS UNABLE TO ADJUST ANY VENTILATOR PARAMETER ON THE EQUIPMENT. THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR. SHE WAS THEN MANUALLY VENTILATED WITH AMBU BAG ON OXYGEN (10 LPM). A PERMANENT PEEP VALVE SET AT 5 CMH2O WAS PREVIOUSLY ATTACHED TO THE RESUSCITATOR TO PROVIDE PEEP. THE PATIENT'S OXYGEN SATURATION REMAINED AT OR ABOVE 98% DURING THE EQUIPMENT CHANGE. CARDIAC STATUS DID NOT APPEAR DIFFERENT THAN PRIOR TO THE CHANGE.EQUIPMENT SENT TO CLINICAL ENGINEERING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO I VENTILATOR CBK MAQUET, INC. 64-49-701-E407E *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention