BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3792098 · Received January 8, 2014

    Report

    Report Number
    1720753-2014-00295
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 17, 2014
    Report Date
    January 8, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. 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 THE SYSTEM INTERMITTENTLY FAILED TO ALLOW FLUOROSCOPIC EXPOSURES AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12664 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1