BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2940893 · Received January 16, 2013

    Report

    Report Number
    1720753-2013-00740
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 16, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE MONOBLOCK CONTROLLER BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED "EEPROM ERROR" WHEN THE FLUORO SWITCH WAS PRESSED CAUSING THE OPERATOR TO HAVE TO REBOOT. 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
    24966 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1