BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2040693 · Received March 22, 2011

    Report

    Report Number
    9680959-2011-00821
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    December 9, 2010
    Report Date
    March 22, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CONTROL BOARD WAS REPLACED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7700 SYSTEM WOULD NOT PRODUCE FLUOROSCOPIC X-RAYS. NO PT 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