BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3874312 · Received April 18, 2014

    Report

    Report Number
    1720753-2014-03423
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 18, 2014
    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 GIB PCB ASSEMBLY WAS EVALUATED AND REPLACED. 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 RESULTED IN A LOSS OF SYSTEM FUNCTIONALITY AND REQUIRED A REBOOT TO REGAIN SYSTEM FUNCTIONALITY. 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
    238780 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1