BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1153627 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22275
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPAIRED THE PROBLEM BY REINSERTING THE POWER CORD BACK INTO THE STRAIN RELIEF CONNECTOR AND TIGHTEN THE CONNECTOR. HE ALSO ADJUSTED THE I.I HOLDER THAT WAS LOOSE. CHECKED SYSTEM FUNCTION AND FOUND TO OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE POWER CORD THAT GOES INTO THE WORKSTATION WAS PULLED OUT SO THAT THE INTERNAL WIRES WERE EXPOSED. THE SYSTEM WAS STILL OPERATIONAL AND THE CUSTOMER WAS STILL USING IT. NO PT INJURY WAS REPORTED.

    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