BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3151404 · Received May 30, 2013

    Report

    Report Number
    1720753-2013-06562
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS INTERFACE BOARD AND THE SMART POWER SWITCH WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM HAD INTERMITTENT X-RAY DISABLED MESSAGE WHICH MAY CAUSE THE SYSTEM TO LOCK UP. THE CUSTOMER REPORTED THAT THEY HAD TO REBOOT THE SYSTEM IN ORDER TO PROCEED. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237816 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1