BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT INCUBATOR

    MDR report key: 33513 · Received June 18, 1996

    Report

    Report Number
    MW1009327
    Event Type
    Malfunction
    Date Received
    June 18, 1996
    Date of Event
    June 1, 1996
    Report Date
    June 18, 1996
    Manufacturer
    DRAGER CRITICAL CARE SYSTEMS, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CO HAS TESTED THE ELECTRONICS UNIT OF THE INCUBATOR 8000 IC WITH INTENSITIES FROM 3 V/M UP TO 10 V/M (SEE TEST RESULTS). THE RESULT IS THAT THE INCUBATOR DOES NOT SHOW ANY PROBLEMS WITH FIELD UP TO 3 V/M, AS REQUIRED IN FDA PERFORMANCE SPECIFICATIONS. IN A SPECIFIC FREQUENCY BAND AND FIELD INTENSITY BETWEEN 5 AND 6 V/M, THE REACTION OF THE INCUBATOR RESULTED IN THE MDR REPORT THE EVENY OF JANUARY 10TH. EVEN THOUGH THE PRODUCT DOES FULLY COMPLY WITH THE IEC AND FDA ENVIRONMENTAL REQUIREMENTS, DRAGER INC. IS UPGRADING ALL CPU'S IN DRAGER INCUBATORS SOLD IN THE US AND CANADA DURING ROUTINE SVC INSPECTIONS. THIS WILL FURTHER ENHANCE THE RESISTANCE AGAINST ELECTRO MAGNETIC FIELDS BEYOND THE CURRENT INTL REQUIREMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO