BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT VENTILATOR

    MDR report key: 33439 · Received June 17, 1996

    Report

    Report Number
    MW1009309
    Event Type
    Malfunction
    Date Received
    June 17, 1996
    Date of Event
    April 1, 1995
    Report Date
    June 14, 1996
    Manufacturer
    DRAGER CRITICAL CARE SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DRAGER, INC. CRITICAL CARE SYSTEMS, 4101 PLEASANT VALLEY RD, STE 100, CHANTILLY, VA 22021. THE DRAGER INC. COMPLAINT FILE DOES NOT HAVE ANY RECORDS WITH THIS PROBLEM. THE "OXYGEN BLENDER" OF THE BABYLOG 8000 IS AN INTEGRATED MICROPROCESSOR CONTROLLED DIGITAL VALVE ARRAY OF 10 VLVES FOR EACH AIR AND OXYGEN, WITH AN AUTOMATIC MICROPROCESSOR CONTROLLED SWITCHOVER, IN THE CASE OF INSUFFICIENT SUPPLY PRESSURE FOR EITHER AIR OR OXYGEN. THE VALVE ARRAY IS DIRECTLY CONTROLLED BY THE PNEUMATIC CONTROL BOARD AND PNEUMATIC ANALOG BOARD. ADDITIONALLY, THE BABYLOG 8000 HAS AN INTEGRATED, INDEPENDENT OXYGEN ANALYZER, WHICH WILL TRIGGER AN ALARM IN CASE OF A DEVIATION TO THE SET OXGYEN CONCENTRATION. THE DRAGER INC COMPLAINT FILE CONTAINS REPORTS ABOUT DEFECTIVE PNEUMATIC CONTROL BOARDS. IN THESE CASES, THE BABYLOG 8000 ALWAYS ALARMED VISUALLY AND AUDIBLE. THERE WHERE NO REPORTED INJURIES TO THE PT AS A RESULT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT VENTILATOR VENTILATOR CBK DRAGER CRITICAL CARE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA