BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2934747 · Received January 4, 2013

    Report

    Report Number
    1720753-2013-00197
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SRAM WAS REPLACED 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

    THE CUSTOMER REPORTED MAINFRAME IS NOT BOOTING, BUT WORKSTATION IS WORKING PROPERLY. THE SYSTEM WOULD BE UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5618 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1