BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2093056 · Received May 3, 2011

    Report

    Report Number
    1720753-2011-06848
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 3, 2011
    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

    THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE IMAGE PROCESSOR BOARD, THE FULL FRAME SCAN CONVERTER, THE MOTHER BOARD, AND THE COMMUNICATIONS PRINTED CIRCUIT BOARDS WERE REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1