BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2030497 · Received March 9, 2011

    Report

    Report Number
    1720753-2011-02035
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 9, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    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 REP CONDUCTED AN ONSITE EVAL. THE VIDEO CARD WAS RESEATED. THE SYSTEM WAS TESTED AND IS NOW OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES ON THE LEFT MONITOR OF THE 6600 SYSTEM WERE NOT CLEAR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1