BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2100-IQ

    MDR report key: 4936557 · Received July 23, 2015

    Report

    Report Number
    9611343-2015-00006
    Event Type
    Death
    Date Received
    July 23, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 23, 2015
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K092004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATION HAS BEEN COMPLETED. GE HEALTHCARE INVESTIGATION CONFIRMED THAT THE REPORTED INCIDENT WAS DUE TO THE FOLLOWING: THE FIRST X-RAY IMAGING FAILURE ISSUE WAS DUE TO AN REAL TIME ACQUISITION COMPUTER (RTAC) DELAYED TASKS AFTER A SYSTEM BOOT LINKED TO AN INCORRECT SOFTWARE/HARDWARE INTERACTION. THE UNSUCCESSFUL SYSTEM REBOOT, WHICH WAS PERFORMED BY THE USER, WAS DUE TO BAD POWER SEQUENCING ON ONE HARDWARE COMPONENT FROM THE RTAC COMPUTER. THE USER DID NOT ATTEMPT TO REBOOT THE SYSTEM FOLLOWING THAT ISSUE. A FIELD ENGINEER PERFORMED MULTIPLE SUCCESSFUL SYSTEM REBOOTS AND ACQUISITIONS INDICATING THAT BOTH OF THESE ISSUES WERE RECOVERED. SYSTEM DIAGNOSTICS DID NOT DETECT ANY PERMANENT SYSTEM ISSUES. GE HEALTHCARE CONFIRMED THAT BOTH ISSUES ARE FULLY RECOVERABLE BY FOLLOWING THE ¿EMERGENCY PROCEDURE FOR IMAGE RECOVERY OR SYSTEM LOCK UP¿ AS RECOMMENDED IN THE OPERATOR MANUAL. HOWEVER, THE USER DID NOT ATTEMPT TO RECOVER THE SYSTEM FUNCTIONALITY BY FOLLOWING THIS PROCEDURE. THEREFORE, NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED WITH THIS ISSUE. THE USER WAS REMINDED BY GE HEALTHCARE TO FOLLOW THE ¿EMERGENCY PROCEDURE FOR IMAGE RECOVERY OR SYSTEM LOCK¿ PROCEDURE FOR THE RECOVERY OF THE SYSTEM. NO PART FAILURE HAS BEEN IDENTIFIED AND NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN INTUBATED UNSTABLE AMI PATIENT WAS TRIAGED THROUGH ER WITH CPR INTO A CATH-LAB WHERE AN ACCESS SHEATH WAS PLACED BEFORE FLUORO FAILED TO WORK. AFTER 2 REBOOT DELAYS, THE PATIENT WAS TRANSPORTED TO AN ADJACENT BACK UP ROOM WHERE AN IABP WAS INSERTED TO INCREASE HEART MUSCLE O2 AND CO. UNDER FLUORO, A GUIDE WIRE COULD NOT MECHANICALLY CROSS THE LESION AFTER MULTIPLE ATTEMPTS. REPERFUSION COULD NOT BE ESTABLISHED AND PATIENT EXPIRED DUE TO THE UNDERLYING CONDITIONS OF THE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478899 INNOVA 2100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS XCA108

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death