BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 7700

    MDR report key: 1478372 · Received June 26, 2009

    Report

    Report Number
    9680959-2009-00287
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    June 23, 2009
    Report Date
    June 26, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM, AND REPLACED A FUSE, AND RECOMMENDED CUSTOMER HAVE X-RAY TUBE REPLACED. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM IS MAKING ARCHING SOUNDS AND SHUTTING DOWN DURING EXPOSURE. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1