BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 1011854 · Received March 11, 2008

    Report

    Report Number
    1720753-2008-17904
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 COMPONENT HAS BEEN REQUESTED. IDE HARD DRIVE KIT. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENT IS REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFO IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOWUP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6600 SYSTEM WILL NOT BOOT UP FULLY. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 6600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1