BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3792200 · Received January 13, 2014

    Report

    Report Number
    1720753-2014-00436
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVERLOAD FAULT ERROR MESSAGE. THIS ERROR CAUSES THE SYSTEM TO SHUT DOWN, RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN THE DELAY OR CANCELLATION OF A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25013 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1