BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI VIEW WORKSTATION

    MDR report key: 957093 · Received November 30, 2007

    Report

    Report Number
    1220063-2007-00038
    Event Type
    Death
    Date Received
    November 30, 2007
    Date of Event
    November 14, 2007
    Report Date
    November 30, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THE MODEL AND SERIAL NUMBERS OF THE CITED DEVICES AND THE SOFTWARE VERSIONS INVOLVED IN THE REPORTED EVENT, WHICH IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT A PATIENT WAS SET UP WITH TELEMETRY MONITORING BY A CARDIOLOGIST TO MEASURE HEART FREQUENCY. THE PATIENT'S TELEMETRY WAS SENDING ALARMS UNINTERRUPTEDLY FOR DIFFERENT DISTURBANCES AND THE RESPONSIBLE NURSE HAD TO REPLACE/CORRECT THE ELECTRODES A NUMBER OF TIMES. THE NURSE PUT THE TELEMETRY IN STANDBY MODE ON THE CENTRAL STATION. THE NURSE GOT INTERRUPTED AND FORGOT THE PATIENT AND THE TELEMETRY BED WAS LEFT IN STANDBY MODE. THE NURSE FOUND THE PATIENT LATER WITH A VENTRICULAR FIBRILLATION. THE TELEMETRY BED IS STILL IN STANDBY MODE. THE PATIENT PASSES AWAY AFTER UNSUCCESSFUL HEART SAVING ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI VIEW WORKSTATION CENTRAL STATION PATIENT MONITORING SYSTEM DSI DRAEGER MEDICAL SYSTEMS, INC. NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Death