BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER BABYLOG

    MDR report key: 66417 · Received January 2, 1997

    Report

    Report Number
    66417
    Event Type
    Injury
    Date Received
    January 2, 1997
    Date of Event
    July 10, 1996
    Report Date
    July 30, 1996
    Manufacturer
    DRAGER, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    ALARMED AND GAVE ERROR CODE 809. PT CHEST NOT MOVING. WHILE PLACING PT ON BAG/VALVE MASK FOR VENTILATION, MACHINE BEGAN CYCLING. WITHIN MINS MACHINE AGAIN BEGAN ALARMING WITH SAME ERROR CODE. PT HAND VENTILATED AND PLACED ON DIFFERENT VENT. SETTINGS CHANGED FROM SIMV TO IMV. ONGOING EVALUATION WITH MFG TO DETERMINE SOURCE OF MALFUNCTION REPORTED PREVIOUSLY TO MFG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention