BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1579433 · Received December 18, 2009

    Report

    Report Number
    9617766-2009-00958
    Event Type
    Malfunction
    Date Received
    December 18, 2009
    Date of Event
    November 24, 2009
    Report Date
    December 15, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE GE SERVICE REP FOUND THAT THE ISSUE HAPPENED DURING A CRITICAL TIME DURING A CRITICAL PROCEDURE. WHEN HE ARRIVED AT THE SITE, THE SYSTEM WAS TURNED OFF. HE STARTED THE BOOT UP PROCEDURE, AND THE PROBLEM STARTED AGAIN. HE OPENED THE LFX1 CABINET AND COULD SEE THE LFX CPU LED ON RESET STATE, CYCLING INTO HALT AND RESET. THE POK LED ON LFX RACK POWER SUPPLY WAS ON, AS OTHERS LEDS ON LFX RACK POWER SUPPLY BOARD. HE TURNED OFF THE ADVANTX CONSOLE, TURNED OFF LFX1 RACK POWER SUPPLY, THE REMOVED LFX RACK POWER SUPPLY BOARD AND THE LFX CPU BOARD FROM THE RACK, AND PERFORMED A VISUAL INSPECTION. EVERYTHING LOOKED NORMAL, SO HE RECONNECTED THEM BACK TO THE MORTARBOARD, AND TURNED ON THE SYSTEM. THERE WASN'T ANY MORE ERROR MESSAGES AS IT IS RIGHT NOW. THE REP RAN SOME DIAGNOSTICS ON THE WHOLE LFX MODULE AND FOUND NO FAILURE. AS A PREVENTIVE ACTION, HE ORDERED AND REPLACED BOTH BOARDS - LFX CPU AND LFX RACK POWER SUPPLY. FROM THAT DATE TO NOW, THERE WEREN'T ANY OTHER FAILURE REPORTS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOLLOWING A VASCULAR SYSTEM FAILURE, THE MOBILE C-ARM WAS USED TO DEPLOY A STENT ON THE PT WHO SUFFERED A STRONG PAIN. THE STENT WAS NOT CORRECTLY DEPLOYED WHICH IMPLIES SOME COMPLICATIONS FOR THE PT. THE PT HAS BEEN TRANSFERRED TO ANOTHER HOSPITAL TO DEPLOY A SECOND STENT. ULTIMATELY, THE SYSTEM DISPLAYED A COMMUNICATIONS ERROR MESSAGE. SEQUENCE OF EVENTS WAS AS FOLLOWS: FOLLOWING THE ADVANTX BREAK DOWN, THE CUSTOMER CONTINUED THE PROCEDURE USING A MOBILE C-ARM. THE C-ARM WAS IN USE AT THIS TIME BY A SURGERY TEAM. AFTER 20 MINUTES, THE SYSTEM WAS FREE AND IMMEDIATELY BROUGHT TO THE CATHLAB WHERE THE CARDIAC PROCEDURE COULD BE CONTINUED. USING THE MOBILE C-ARM THE CARDIOLOGIST PUT A STENT TO THE LEFT CORONARY ARTERY. THE STENT WAS NOT PLACED CORRECTLY BECAUSE IT DIDN'T COVER THE WHOLE STENOSED AREA OF THE VESSEL. THE PT HAS BEEN TRANSPORTED TO ANOTHER HOSP WHERE THE CARDIOLOGIST HAS PLACED AN ADDITIONAL STENT WHICH COVERED THE MISSING STENOSIS AREA. IN THE END, THE PT REC'D 2 STENTS. THE PT IS FEELING BETTER NOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization