BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1220647 · Received October 31, 2008

    Report

    Report Number
    9617766-2008-01415
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 31, 2008
    Manufacturer
    GE BE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP INSTALLED THE HV TRANSFORMER, SBC, POWER SUPPLY AND BACK PLANE. THE SBC STILL WOULD NOT POWER UP. HE ISOLATED THE SBC AND BACKPLANE AND STILL NOTHING. HE TRACED THE 5V TO THE POWER DISTRIBUTION BOARD AND IT DROPPED TO 1.65V AT P9. HE ISOLATED THE POWER SUPPLY AND STILL NO 5V. HE ORDERED THE POWER DISTRIBUTION AND CABLE AND INSTALLED PARTS AND THE SYSTEM BOOTED PROPERLY. THE SYSTEM HAS BEEN PLUGGED INTO AN APC UPS RATED AT 12 AMPS DURING ITS EVERYDAY USE. THE GE REP PLUGGED THE SYSTEM DIRECTLY INTO THE RED 15AMP OUTLET AFTER SERVICE WAS COMPLETE. HE HAD SPOKEN WITH THE CUSTOMER ABOUT THE UPS NOT BEING VALIDATED FOR OUR SYSTEMS AND WE DO NOT RECOMMEND USING IT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WILL NOT BOOT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE BE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1