BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3151375 · Received May 30, 2013

    Report

    Report Number
    1720753-2013-06572
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SENSOR WAS ADJUSTED 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 THE SYSTEM DISPLAYED A COMMUNICATION ERROR. A COMMUNICATION FAIL ERROR MESSAGE WILL LIKELY RESULT IN A SYSTEM LOCKUP, NO BOOT OR SHUT DOWN SITUATION. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237776 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1