BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2934726 · Received January 4, 2013

    Report

    Report Number
    1720753-2013-00201
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION WAS NOT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE SYSTEM HAD A GENERATOR ERROR MESSAGE AND INTERMITTENT EXPOSURES. THE ERROR MESSAGE APPEARS WHEN THE SYSTEM DETECTS AN ERROR IN ANY OF THE REGISTERS ASSOCIATED WITH THE HIGH VOLTAGE GENERATOR. THE SYSTEM SHUTS DOWN WHEN THIS OCCURS. 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
    5535 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1