BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2100-IQ

    MDR report key: 4349356 · Received December 22, 2014

    Report

    Report Number
    9611343-2014-00080
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    November 26, 2014
    Report Date
    November 26, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K092004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND AGE WERE NOT PROVIDED.INITIAL REPORTER EMAIL WAS NOT PROVIDED.GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED. ON (B)(6) 2014, IT WAS REPORTED THAT A SHORT OBESE FEMALE PATIENT ((B)(6)) WAS VERY UNCOMFORTABLE ON THE TABLE AFTER THE COMPLETION OF THE PROCEDURE. THE PATIENT ROLLED OFF ONTO HER LEFT SIDE WHILE READJUSTING TO POSITION HERSELF AND RESULTING IN SUBARACHNOID BLEED. DURING THE INCIDENT 3 HEALTH CARE PROFESSIONALS WERE PRESENT INSIDE THE ROOM, AND THE PATIENT WAS UNGUARDED AND WAS NOT SECURED WITH VELCRO STRAPS. BEFORE THE INCIDENT, THE CARDIOLOGIST COMPLETED THE PROCEDURE AND PULLED THE SHEATH FROM THE RADIAL ARTERY AND HEMOSTASIS WAS OBTAINED. THE PATIENT SUSTAINED A LEAKAGE OF BLOOD INTO THE SUBARACHNOID SPACE, WHICH WAS CONFIRMED BY CT, AND THE PATIENT WAS KEPT IN THE INTENSIVE CARE UNIT FOR ONE WEEK OF OBSERVATION BEFORE DISCHARGE. THE PATIENT HAD BEEN ON ANTICOAGULATION THERAPY DUE TO CORONARY STENT PLACEMENT. THE GE HEALTHCARE SYSTEM HAD NO ISSUES DURING THE EXAM PROCEDURE AND WAS COMPLETED SUCCESSFULLY. THE CUSTOMER STATED THAT THE SYSTEM DID NOT CAUSE THE PATIENT FALL AND NO SYSTEM MALFUNCTION WAS REPORTED. THE CUSTOMER DID NOT USE VELCRO STRAPS UNTIL NOW AND WAS NOT AWARE OF THE IMPORTANT PRACTICE OF USING THESE VELCRO STRAPS. GE HEALTHCARE SUPPLIES VELCRO STRAPS AND THE HEAD HOLDER AS PART OF THE TABLE TO WELL SECURE THE PATIENT ON THE TABLE. INSTRUCTIONS IN THE OPERATOR MANUAL CLEARLY WARNS TO NEVER LEAVE THE PATIENT UNATTENDED AND RECOMMENDS TO USE RESTRAINTS, SUCH AS VELCRO STRAPS. AN APPLICATION TRAINING WAS PERFORMED AFTER THE COMPLETION OF SYSTEM INSTALLATION, AND COVERS INFORMATION ABOUT THE USAGE OF VELCRO STRAPS TO SUPPORT THE PATIENT ON THE TABLE. THE ROOT CAUSE IDENTIFIED FOR THIS ISSUE IS THAT USER LEFT THE PATIENT UNGUARDED AND DID NOT SECURE THE PATIENT WITH VELCRO STRAPS, AGAINST THE INSTRUCTIONS FOR USE AND IN-SERVICE TRAINING RECOMMENDATION. ON (B)(6) 2014, THE GE HEALTHCARE CLINICAL SPECIALIST REMINDED THE HOSPITAL'S RISK MANAGER TO USE THE VELCRO STRAPS PER THE OPERATOR MANUAL AND SECURE THE PATIENT PER RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE. INFORMATION ON THE PATIENT'S AGE WAS NOT PROVIDED. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING STENT PLACEMENT, THE PATIENT WAS VERY UNCOMFORTABLE ON THE TABLE. THE EXAM WAS COMPLETED SUCCESSFULLY. THE PATIENT READJUSTED HERSELF DUE TO BEING UNCOMFORTABLE AND FELL FROM THE TABLE TO THE FLOOR, RESULTING IN SUBARACHNOID BLEED. THE PATIENT HAD NOT BEEN SECURED WITH SAFETY STRAPS AND MEDICAL STAFF WAS PRESENT IN THE ROOM. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841467 INNOVA 2100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS XCA220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other