BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE OEC 9900 ELITE

    MDR report key: 880000 · Received July 13, 2007

    Report

    Report Number
    1720753-2007-03216
    Event Type
    Death
    Date Received
    July 13, 2007
    Date of Event
    March 27, 2007
    Report Date
    July 11, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    PMA / PMN Number
    K041931
    Removal / Correction Number
    Z-0042-2007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS INVESTIGATED BY GE HEALTHCARE AND GE HEALTHCARE REPRESENTATIVES. THE MALFUNCTION COULD NOT BE DUPLICATED. THIS SYSTEM IS LOCATED IN THE UNITED KINGDOM. FURTHER VERBAL INFO PROVIDED TO THE GE SERVICE REP FROM, THE FACILITY, REVEALED THAT THE PT DEATH DURING A CORONARY ANGIOGRAPHY PROCEDURE OCCURRED ON 03/27/07. THERE ARE NO NOTED SERVICE REQUESTS FOR THE 9900 SYSTEM UNTIL 05/25/07. THERE WAS NO MENTION OF THE PT DEATH, DURING A PROCEDURE UNTIL IN 2007. NOTIFICATION BY THE FACILITY EXCEEDED 60 DAYS. AS OF 07/02/07, THE FACILITY WOULD NOT PROVIDE FURTHER INFO ON THE PT INVOLVED. THE GE OEC 9900 ELITE FLUOROSCOPY SYSTEM HAS A KNOWN LOCK-UP ISSUE AND HAS BEEN ADDRESSED UNDER CURRENT RECALL NOTIFICATIONS AND PENDING FMI ACTIONS. ALL USERS ARE INSTRUCTED ON STEPS TO BE USED TO MITIGATE CURRENT LOCK-UP ISSUES, SHOULD THEY OCCUR DURING PROCEDURES. THE FACILITY HAS NOT BEEN INCLINED TO FURNISH MORE SPECIFIC DETAILS WITH RESPECT TO THE NOTED INCIDENT. AT THE TIME GE SERVICE WAS NOTIFIED OF THE ALLEGED DEATH, THE EVENT LOGS ON THE SYSTEM DID NOT REVEAL ANY RELEVANT INFO PERTAINING TO THE DATE OF INCIDENT. THERE ARE CONTINUING EFFORTS TO OBTAIN FURTHER INFO AND DOCUMENTATION ABOUT THIS INCIDENT FROM THE FACILITY. IF FURTHER INFO IS REC'D, A FOLLOW-UP REPORT WILL BE ISSUED FORTHWITH.

    Description of Event or Problem · 1

    THE GE OEC 9900 FLUOROSCOPY SYSTEM REPORTEDLY HAD SYSTEM LOCK-UP ISSUES IN 2007. THE CUSTOMER ALLOWED ACCESS TO THE SYSTEM ON THE FOLLOWING MONTH. NO ERROR COULD BE REPRODUCED. ON FIVE DAYS LATER, ON SITE MONITORING HAD NO ERRORS AND THE EVENT LOG WAS RETRIEVED AND SENT FOR ANALYSIS. ON TWELVE DAYS LATER, ADDITIONAL ON-SITE MONITORING HAD NO LOCK-UPS OR ISSUES, AND 7 PROCEDURES WERE PERFORMED WITH THE SYSTEM, WITHOUT ISSUE. ON THE SERVICE VISIT ON THE SAME DAY, THE SERVICE REPRESENTATIVE WAS TOLD OF A POTENTIAL RELATION TO THE SYSTEM LOCK-UP ISSUES AND A PT DEATH. ON THREE DAYS LATER, THE EVENT LOG WAS AGAIN RETRIEVED AND SENT FOR ANALYSIS. DURING THE SERVICE VISIT ON THE SAME DAY, THE GE SERVICE REP WAS INFORMED: "ON APPROX THREE WEEKS EARLIER, DEATH OF PT DURING CORONARY ANGIO DUE TO FAILURE OF XRAY EQUIPMENT AND NEED TO RESTART FREQUENTLY. CAUSED SIGNIFICANT DELAY AND REPEATED ENGAGEMENT OF CORONARY ARTERY" WITH NO ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9900 ELITE FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC GE OEC 9900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death