BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2000

    MDR report key: 6266056 · Received January 20, 2017

    Report

    Report Number
    9611343-2017-00001
    Event Type
    Death
    Date Received
    January 20, 2017
    Date of Event
    December 22, 2016
    Report Date
    January 20, 2017
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT AND/OR PRODUCT PROBLEM WAS UPDATED TO REFLECT NO SYSTEM CAUSE OF CONTRIBUTION TO THE PATIENT DEATH. REPORT DATE WAS UPDATED TO 01/20/2017. INITIAL REPORTER EMAIL NOT PROVIDED. IT WAS REPORTED THAT A PATIENT WITH A MYOCARDIAL INFARCTION WAS ADMITTED FOR AN EMERGENCY PRIMARY ANGIOPLASTY IN MYOCARDIAL INFARCTION. AFTER 5 MIN OF FLUOROSCOPY, SYSTEM STARTED GIVING AN ALARM. TECHNICIAN DID NOT NOTICE THE ALARM AND CONTINUED TO PERFORM FLUOROSCOPY. AFTER 10 MIN OF FLUOROSCOPY, SYSTEM STOPPED THE FLUOROSCOPY AND GAVE ERROR MESSAGE. AT THIS TIME, TECHNICIAN SHOULD HAVE RESET THE FLUORO TIMER ALARM AND STARTED THE FLUOROSCOPY AGAIN NORMALLY. BUT INSTEAD, THE TECHNICIAN UNNECESSARILY REBOOTED THE SYSTEM WHICH TOOK ~3-4 MINUTES. THE SAME SCENARIO HAPPENED A SECOND TIME DURING THAT EXAM RESULTING IN ENDO-TRACHEAL INTUBATION PATIENT. PATIENT WAS SHIFTED ON VENTILATOR TO INTENSIVE CARE UNIT AFTER A SUCCESSFUL COMPLETION OF CASE. DESPITE, THE PATIENT LEFT THE PROCEDURE ROOM IN STABLE/GUARDED CONDITION, HE EXPIRED ON (B)(6) 2016 EVENING. IT WAS CONCLUDED THAT THE GE MEDICAL DEVICE DID NOT FAIL, AND OPERATED WITHIN SPECIFICATION. THERE WAS NO SYSTEM CAUSE OR CONTRIBUTION TO THAT ADVERSE EVENT SINCE THE PATIENT SUCCUMBED TO THE NATURAL HISTORY OF HIS ILLNESS. THE MOST PROBABLE ROOT CAUSE IS A USE ERROR. IT WAS CONFIRMED THAT THE EXAM WAS PERFORMED BY A TRAINEE TECHNICIAN. HOWEVER, HE WAS NOT AWARE ABOUT THE FLUOROSCOPY TIMER FEATURE. ON (B)(6) 2016 CUSTOMER WAS REMINDED ABOUT FLUORO TIMER FEATURE AND RESET FUNCTION. NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER EMAIL NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE HEALTHCARE THAT THE FLUOROSCOPY IMAGING MODE WAS TEMPORARILY ABORTED DURING CRITICAL PHASE OF AN EMERGENCY PRIMARY ANGIOPLASTY IN MYOCARDIAL INFARCTION (PAMI) PROCEDURE. A TEN (10)-MINUTE FLUOROSCOPIC ALERT TIMER WAS NOT RESET TWO TIMES BY FLUOROSCOPIST DURING THE EXAM. IT HAPPENED TWICE DURING THE CASE, FIRST TIME WHEN WIRE WAS BEING INSERTED IN THE ARTERY AND SECOND TIME FLUOROSCOPY STOPPED WHEN THE STENT WAS AT PLACE IN THE ARTERY AND WAS ABOUT TO BE INFLATED. IT TOOK AROUND 3-4 MINUTES TO RESTART THE SYSTEM AND THEN FLUOROSCOPY STARTED AGAIN NORMALLY. FLUOROSCOPY WAS NEEDED DURING THIS DELAY AS THE STENT WAS IN PLACE AND THEY HAD TO INTUBATE THE PATIENT DUE TO THIS DELAY SINCE PATIENT CONDITIONS STARTED TO DETERIORATE. CASE WAS COMPLETED AFTER SYSTEM REBOOT BUT PATIENT PASSED AWAY THE DAY AFTER ((B)(6) 2016).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50772 INNOVA 2000 INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death