BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE MEDICAL SYSTEMS, IT

    MDR report key: 448599 · Received March 14, 2003

    Report

    Report Number
    2124823-2003-00014
    Event Type
    Malfunction
    Date Received
    March 14, 2003
    Date of Event
    August 5, 2002
    Report Date
    March 13, 2003
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    KNG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNIT SMOKED WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE MEDICAL SYSTEMS, IT FETAL MONITOR KNG GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 0128AAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN