BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABYLOG 8000

    MDR report key: 1130914 · Received August 7, 2008

    Report

    Report Number
    2517967-2008-00011
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    June 14, 2008
    Report Date
    July 31, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: WHILE THE BABYLOG 8000 WAS VENTILATING A PT, THE FLOW SENSOR HOUSING BROKE WITHOUT USER INTERACTION. A PIECE OF THE FLOW SENSOR REMAINED STUCK IN THE ENDOTRACHEAL TUBE ADAPTER WHEN THE FLOW SENSOR HOUSING BROKE, RESULTING IN IMMEDIATE INTERACTION BY THE STAFF TO EXTUBATE, BAG, THEN REINTUBATE THE PT. THE PT'S OXYGENATION LEVEL AND HEART RATE DEPRESSED FOR A PERIOD. NO SERIOUS INJURY OR PERMANENT DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABYLOG 8000 NEONATAL VENTILATOR CBK DRAEGER MEDICAL AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention