BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2062421 · Received April 12, 2011

    Report

    Report Number
    9680959-2011-01049
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    November 11, 2010
    Report Date
    April 12, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CONTROLLER WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7700 SYSTEM WAS NOT REGULATING THE DOSE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1