BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGER BABYLOG 8000

    MDR report key: 278190 · Received May 16, 2000

    Report

    Report Number
    MW1018900
    Event Type
    Malfunction
    Date Received
    May 16, 2000
    Date of Event
    May 5, 2000
    Report Date
    May 11, 2000
    Manufacturer
    DRAGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    DRAGER BABYLOG 8000 VENTILATOR ALARMED. DISPLAY READ MALFUNCTION ERROR 806. REMOVED VENTILATOR FROM PT AND REPLACED WITH ANOTHER VENTILATOR. FLOW SENSOR "INOP". VENT SENT TO IN-HOUSE BIOMED DEPT FOR EVALUATION. DRAGER CALLED TO EVALUATE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER BABYLOG 8000 VENTILATOR CBK DRAGER, INC. 8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO