BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER BABYLOG

    MDR report key: 66413 · Received January 2, 1997

    Report

    Report Number
    66413
    Event Type
    Injury
    Date Received
    January 2, 1997
    Date of Event
    June 12, 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

    VENTILATOR ALARMED - SCREEN READ "VENT MALFUNCTION, ERROR CODE 004". PT REMOVED AND HAND VENTILATED. VENT REPLACED AND PT PLACED BACK ON VENT WITH SME SETTINGS, CHANGED MODE FROM SIMV TO IMV. NO ADVERSE OUTCOME TO PT. DUE TO ERROR CODE, EVALUATED POWER SUPPLY AND THERE WAS REPORTED POWER SURGE ON THIS DAY. CO CALLED AND PARTICIPATING IN IDENTIFYING MALFUNCTION SOURCE.

    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 5 DAY Required Intervention