BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1419745 · Received April 13, 2009

    Report

    Report Number
    1720753-2009-03076
    Event Type
    Malfunction
    Date Received
    April 13, 2009
    Date of Event
    March 20, 2009
    Report Date
    April 13, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FORMATTED THE HARD DRIVE, BUT IT FAILED THE CHECK DISK. HE REMOVED AND REPLACED THE HARD DRIVE, FLASHED THE NODES, RELOADED THE APPS SOFTWARE, AND CONFIGURED THE FILES. THE SYSTEM BOOTED UP SEVERAL TIMES AND THEN FAILED TO BOOT - INDICATING THE SBC WAS DEFECTIVE. HE REMOVED AND REPLACED THE SBC, THE SYSTEM INTERFACE, THE IMAGE PROCESSOR AND GEN INTERFACE PCBS. HE FLASHED THE NODES, RELOADED THE VER 29, BUT COULD NOT LOAD THE SOFTWARE HARD DRIVE THAT WAS DEFECTIVE, (DOA). HE COULD NOT FORMAT THE HARD DISK DRIVE, SO HE ORDERED AND INSTALLED A NEW HARD DRIVE AND LOADED VER 29 SOFTWARE AND LOADED THE CONFIGURATION FILES SUCCESSFULLY. THE REP COULD NOT DUPLICATE THE COLLIMATOR IRIS ERROR. HE CALIBRATED THE COLLIMATOR IRIS STOPS. HE TESTED THE SYSTEM AND BOOTED IT SEVERAL TIMES WITHOUT ISSUES. THE SYSTEM FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS SLOW TO BOOT UP. IT ALSO WAS REPORTED THAT THE COLLIMATOR IRIS WAS TOO LARGE AND AN ERROR CODE APPEARED ON THE SYSTEM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1