BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3792127 · Received January 8, 2014

    Report

    Report Number
    1720753-2014-00278
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 26, 2013
    Report Date
    January 8, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. CONFIRMED SYSTEM VOLTAGE WAS WITHIN SPECIFICATIONS. SYSTEM PCB ASSEMBLIES WERE REMOVED AND RESEATED. THE FOOTSWITCH WAS ALSO REPLACED AS PART OF THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR IS LIKELY TO RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12690 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1