BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3010925 · Received March 14, 2013

    Report

    Report Number
    1720753-2013-03783
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE IMAGE PROCESSOR BOARD WAS IDENTIFIED AS REQUIRING REPLACEMENT. THE CUSTOMER IS CURRENTLY CONSIDERING REPAIR VERSUS SYSTEM REPLACEMENT OPTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE PIXELATED TO THE POINT THAT THEY REMOVED THE SYSTEM FROM SVC. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108387 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1