BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4173334 · Received October 10, 2014

    Report

    Report Number
    1720753-2014-08504
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 25, 2014
    Report Date
    October 9, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GIB COIN BATTERY WAS EVALUATED AND REPLACED. THE BACKPLANE AND FUSES WERE EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM HAD A COMMUNICATION FAILED ERROR. THE FIELD ENGINEER NOTED THAT THE CUSTOMER COULD NOT USE C-ARM, THERE WAS NO FLUORO. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. 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
    643428 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1