BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1021744 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19718
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SVC REP REPLACED THE HIGH VOLTAGE CABLE AND REAR HANDLE. MACHINE FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE MINI C-ARM HAD A CRACK IN THE PLASTIC PIECE HOLDING ON THE HIGH VOLTAGE CABLE AND THAT SYSTEM REAR HANDLE WAS VERY LOOSE. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1