BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3921433 · Received May 21, 2014

    Report

    Report Number
    1720753-2014-04461
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 23, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ON SITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXHIBITED 'PRE-CHARGE VOLTAGE ERRORS' UPON SYSTEM START UP. THIS ERROR IS LIKELY TO PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304033 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1