BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1322779 · Received February 24, 2009

    Report

    Report Number
    1720753-2008-29227
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    November 21, 2008
    Report Date
    December 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SVC REP REPLACED THE PS1 IN WS AND SBC CPU. THE SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATIONS ERROR ON THE WORKSTATION AND AN X-RAYS BLOCK ERROR MESSAGE ON THE CONTROL PANEL. THEY FOUND THAT AFTER THE SYSTEM WAS ON FOR A WHILE, THE SYSTEM WOULD START REBOOTING ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY SYSTEM JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1