BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2884853 · Received December 3, 2012

    Report

    Report Number
    1720753-2012-09900
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RELOADED SOFTWARE AND REPLACED THE UPS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A FILE CORRUPTION ERROR. THIS ERROR CAUSES THE SYSTEM TO LOCK UP OR NOT TO BOOT. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1