BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3823192 · Received March 20, 2014

    Report

    Report Number
    1720753-2014-02559
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED. THE CUSTOMER HAS REFUSED SERVICE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR IS LIKELY TO RESULT IN A SYSTEM LOCK UP, NO BOOT OR SHUT DOWN DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. 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
    167728 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1