BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3960264 · Received June 24, 2014

    Report

    Report Number
    1720753-2014-05393
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    December 20, 2013
    Report Date
    June 23, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE IMAGE PROCESSOR BOARD WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE IMAGE PROCESSING CARD (IPC) WAS DEFECTIVE, WHICH RESULTED IN A LOSS OF LIVE IMAGE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367384 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1