BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 2934274 · Received January 7, 2013

    Report

    Report Number
    1720753-2013-00269
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    September 18, 2012
    Report Date
    January 7, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND DETERMINED THE LIFT ROLLER NEEDED TO BE REPLACED, BUT THE PART IS NO LONGER AVAILABLE AS THIS PRODUCT IS BEYOND "END OF LIFE." NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIMES AN ERROR 100 APPEARS ON THE WORKSTATION AND X-RAYS ARE NOT AVAILABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8663 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1