BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3792095 · Received January 8, 2014

    Report

    Report Number
    1720753-2014-00299
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 8, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE ROTOR MOTOR PCB WAS EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. THE CUSTOMER DECLINED TO HAVE FURTHER SERVICE PERFORMED BY GE. 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 THE SYSTEM FAILED OT 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
    12663 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1