BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1002756 · Received February 26, 2008

    Report

    Report Number
    1720753-2008-16396
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN INVESTIGATION. BASED ON INFO PROVIDED, THE FOLLOWING COMPONENTS HAVE BEEN ORDERED. SINGLE BOARD COMPUTER KIT AND IMAGE PROCESSOR PCB. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFO IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY THE 6800 SYSTEM WILL NOT BOOT UP. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1