BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 984167 · Received January 25, 2008

    Report

    Report Number
    1720753-2008-00849
    Event Type
    Malfunction
    Date Received
    January 25, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFORMATION PROVIDED THE FOLLOWING COMPONENTS HAVE BEEN ORDERED. MOTHERBOARD AND CONTROLLER ASSEMBLY PCB. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFORMATION IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOWUP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE ON THE 6600 SYSTEM WENT BLANK. THE SYSTEM WAS REBOOTED AND OPERATION RESTORED. IT WAS NOTED THAT THE SYSTEM THEN RANDOMLY GENERATED BEEPING SOUNDS WHILE SITTING IDLE (WHEN FOOTSWITCH IS RELEASED). THERE WAS NO REPORT OF PATIENT 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 UNK