BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1003933 · Received January 30, 2008

    Report

    Report Number
    1003933
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 30, 2008
    Manufacturer
    VIASYS HEALTHCARE MEDSYSTEMS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE OPERATING VENTILATOR ON BATTERIES, VENTILATOR WOULD GO INTO LOW BATTERY ALARM AFTER VERY SHORT PERIODS OF TIME DESPITE BATTERY INDICATORS SHOWING FULLY CHARGED BATTERIES. THERE WERE A COUPLE OF INSTANCES WHERE VENTILATOR FAILED TO SWITCH FROM EXTERNAL TO INTERNAL BATTERIES DESPITE INDICATIONS OF FULLY CHARGED BATTERIES. IN ALL CASES, VENTILATION FUNCTION STOPPED AND VENTILATOR WENT INTO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * VENTILATOR CBK VIASYS HEALTHCARE MEDSYSTEMS AVEA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *