BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3772106 · Received January 2, 2014

    Report

    Report Number
    1720753-2014-00045
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 13, 2013
    Report Date
    January 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE EVALUATED THE SYSTEM AND REPAIRED IT. A FAULT WAS DETECTED WITH THE GIB NODE; NO FURTHER REPAIR INFO IS AVAILABLE. THE SYSTEM OPERATES AS INTENDED AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY A FLUOROSCOPIC IMAGE. THIS RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1