BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3802114 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13881
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 12, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY PS1 ON THE MAINFRAME WAS EVALUATED AND REPLACED, AND THE VOLTAGE WAS ADJUSTED TO 5.2VDC. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COMMUNICATION FAILURE ERROR MESSAGE, WHICH MAY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679401 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1