BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2030209 · Received March 7, 2011

    Report

    Report Number
    1720753-2011-01971
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 7, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE DUE TO PART BEING ON BACK ORDER. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON OCCASION THE 6800 SYSTEM WILL FAIL TO BOOT UP. 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