BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2090578 · Received April 26, 2011

    Report

    Report Number
    1720753-2011-06531
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 6800 SYSTEM HIGH VOLTAGE CABLE ASSEMBLY WAS BROKEN AND THE IMAGE RESOLUTION WAS TOO LOW. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1