BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3811088 · Received March 24, 2014

    Report

    Report Number
    1720753-2014-02652
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SRAM WAS EVALUATED AND IDENTIFIED AS AN END OF LIFE COMPONENT. NO REPAIR COULD BE COMPLETED AND THE CUSTOMER DISCONTINUED USE OF THE DEVICE. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM FAILED TO ALLOW FLUOROSCOPIC EXPOSURES AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173400 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1