BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1220685 · Received October 31, 2008

    Report

    Report Number
    9680959-2008-00205
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 30, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP MEASURED THE RESOLUTION WITH THE LINE PAIR TOOL PLACED ON THE IMAGE INTENSIFIER. HE MEASURED THE LOW CONTRAST RESOLUTION, USING (2) 3/4" AL BLOCKS AND THE LC PLATE. THE REP CHECKED THE OVERALL OPERATION AND VERIFIED THE SYSTEM PERFORMS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM HAD HIGH CONTRAST RESOLUTION. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1