BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVITA XL

    MDR report key: 1303443 · Received January 12, 2009

    Report

    Report Number
    9611500-2009-00002
    Event Type
    Other
    Date Received
    January 12, 2009
    Report Date
    January 8, 2009
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    PMA / PMN Number
    K980642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY OF THE CONCERNED DEVICE WAS MADE AVAILABLE FOR INVESTIGATION AT MFR SITE. THE INVESTIGATION CAME TO THE RESULT THAT A TRANSISTOR OF THE PRIMARY HOUSEKEEPING LOW VOLTAGE SUPPLY FAILED, CAUSING THE REPORTED DEVICE BEHAVIOUR. THE EVITA 2 DURA REACTED AS SPECIFIED FOR THIS CASE OF FAILURE, OPENED THE AIRWAY SYSTEM TO ALLOW SPONTANEOUS BREATHING FOR THE PT AND POSTED AN ACOUSTICAL ALARM. THE POWER SUPPLY OF THE EVITA IS DESIGNED AND APPROVED IN ACCORDANCE TO UL94. THE REPORTED 'SMOKY SMELL' WAS CAUSED BY THE OVERHEATED PLASTIC HOUSING OF THE FAILED TRANSISTOR. THE CONNECTION OF THE TRANSISTOR IS PROTECTED BY A FUSE, CONSEQUENTLY OVER-CURRENT WILL BE INTERRUPTED. THE FAILURE RATE OF THE CONCERNED COMPONENT IS CONTINUOUSLY MONITORED AND EVALUATED WITH THE RESULT THAT IT IS WITHIN THE ACCEPTED RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR STOPPED VENTILATION AND GENERATED AN AUDIBLE ALARM. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA XL CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention