BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3792667 · Received January 20, 2014

    Report

    Report Number
    1720753-2014-00647
    Event Type
    Malfunction
    Date Received
    January 20, 2014
    Date of Event
    December 31, 2013
    Report Date
    January 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE FE REPORTED A FILE CORRUPTION ERROR MESSAGE. THIS ERROR CAUSES THE SYSTEM TO LOCK UP OR NOT TO BOOT. THIS COULD RESULT IN THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46394 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1