BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1910016 · Received November 10, 2010

    Report

    Report Number
    1720753-2010-04034
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 10, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND CORRUPTED SOFTWARE. GE REP REFORMATTED THE CINE DRIVE, AND RELOADED SYSTEM SOFTWARE, CALIBRATION, AND CONFIGURATION FILES. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY STOPS FLUOROING DURING A PROCEDURE AND THE CINE BUTTON INTERMITTENTLY WILL NOT WORK. 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