BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3792397 · Received January 18, 2014

    Report

    Report Number
    1720753-2014-00638
    Event Type
    Malfunction
    Date Received
    January 18, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE THE SERVICE EVALUATE THE SYSTEM AND CANCELLED THE SERVICE CALL. THE CUSTOMER HAS DECIDED TO REPLACE THE DEVICE AND REFUSED FURTHER SERVICE. 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 CUSTOMER REPORTED THAT THERE WAS AN "OVERLOAD FAULT" ERROR DISPLAYED. THIS ERROR IS LIKELY TO RESULT IN AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46350 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1