BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1011834 · Received March 11, 2008

    Report

    Report Number
    1720753-2008-17884
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN INVESTIGATION. BASED ON INFO PROVIDED THE FOLLOWING COMPONENTS HAVE BEEN REQUESTED. MOTHERBOARD, POWER SUPPLY AND A SCAN CONVERTER PCB. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADD'L 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 THE MONITORS ON THE 2600 SYS WOULD 'FLICKER" AND INTERMITTENTLY THE SYS WOULD REBOOT. THIS HAPPENED DURING A CASE, HOWEVER THE CASE WAS COMPLETED AND THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC 2600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK