BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2861663 · Received November 29, 2012

    Report

    Report Number
    1720753-2012-09862
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 29, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE KV CONTROLLER BOARD AND THE GENERATOR INTERFACE BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COMMUNICATION ERROR. THIS ERROR WILL CAUSE THE SYSTEM TO LOCKUP OR NOT TO BOOT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1