BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3980165 · Received July 2, 2014

    Report

    Report Number
    1720753-2014-05629
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE COIN BATTERIES ON RTOS, GPOS, AND GIB WERE REPLACED. THE WORKSTATION AND MAINFRAME PCBS WERE RESEATED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS SHUT DOWN WITHOUT COMMAND. 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
    388798 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1