BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2884854 · Received December 3, 2012

    Report

    Report Number
    1720753-2012-09899
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE INTERCONNECT CABLE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE SPLIT OR UPSIDE DOWN. THE FSE REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SYSTEM, INDICATING THE IMAGES WERE UNUSABLE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    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