BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2934645 · Received January 10, 2013

    Report

    Report Number
    1720753-2013-00435
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE WAS REPLACED AND THE SYS SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED A "FILE SYS CORRUPTION DETECTED" ERROR MESSAGE WHICH WAS NOT RECOVERABLE, THEREFORE, THE SYS WAS RENDERED INOPERABLE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15996 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1