BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1744199 · Received February 12, 2009

    Report

    Report Number
    1720753-2009-01188
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Date of Event
    January 19, 2009
    Report Date
    February 6, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE GE SERVICE REP FOUND THE BLOWN FUSE IN AC/DC MODULE, THEN REPLACED THE COMPLETE GENERATOR AFTER REPLACING MULTIPLE PARTS IN THE GENERATOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED GENERATOR ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1