BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1970116 · Received January 14, 2011

    Report

    Report Number
    1720753-2011-00288
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 14, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE INSPECTED THE SYSTEM AND COULD NOT REPRODUCE ANY ERRORS. GE REPRESENTATIVE CHECKED THE 5VDC AT THE GENERATOR, VERIFIED POWER CORD CONNECTIONS ARE TIGHT, INSPECTED CANDLE STICKS (HIGH VOLTAGE CONNECTORS) FOR ARCING, AND REGREASED THEM, PERFORMED ARC TEST AND SYSTEM DID NOT ARC. REPLACED CONTROL PANEL PROCESSOR AND TESTED SYSTEM, COULD NOT DUPLICATE ANY ERRORS OR PROBLEMS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A CONTROL PANEL ERROR MESSAGE DURING A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1