BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2191252 · Received July 19, 2011

    Report

    Report Number
    1720753-2011-20177
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED THE SERVICE CALL. THE REPORTED PROBLEM WAS RESOLVED BY THE CUSTOMER BY REPAIRING THE CAMERA. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PERFORM FLUOROSCOPIC X-RAY. NO PATIENT 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