BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3093416 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05386
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 26, 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 ON SITE INVESTIGATION. THE SYS SOFTWARE WAS RELOADED AND THE CINE DRIVE WAS REFORMATTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A 'FILE SYS CORRUPTION DETECTION' ERROR MESSAGE AND THE SYS WAS NO LONGER UNUSABLE. THE SYS WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181765 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1