BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 4100-IQ

    MDR report key: 5100878 · Received September 24, 2015

    Report

    Report Number
    9611343-2015-00015
    Event Type
    Death
    Date Received
    September 24, 2015
    Report Date
    August 25, 2015
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATION HAS BEEN COMPLETED. IT WAS REPORTED THAT A SEDATED (B)(6) OLD MALE PATIENT WITH END STAGE RENAL DISEASE, DIABETES MELLITUS TYPE 2, AND HYPERTENSION PRESENTED FOR AN AV FISTULOGRAM, ABRUPTLY SAT UP AND FELL FROM THE TABLE AT THE END OF THE PROCEDURE. SUBSEQUENTLY, CT SCANNING OF THE BRAIN WAS DONE AND SURGERY FOR EVACUATION OF A SUBDURAL HEMATOMA. THE PATIENT DIED ON (B)(6) 2013 DUE TO MULTIPLE REASONS, 2 MONTHS AFTER THE FALL. THE RADIOLOGY TECHNICIAN AND NURSE WERE PRESENT IN THE EXAM ROOM. IT IS NOT CLEAR THEIR POSITION IN THE ROOM. THE PATIENT WAS SECURED WITH VELCRO STRAPS FROM A THIRD PARTY MANUFACTURER. GE HEALTHCARE'S INVESTIGATION CONFIRMED THAT GE HEALTHCARE SUPPLIED VELCRO STRAPS AND A HEAD HOLDER AS PART OF THE INTERVENTIONAL PRODUCT. THE THIRD PARTY VELCRO STRAPS WERE NOT RETURNED FOR EVALUATION; THEREFORE THERE WAS NO ASSESSMENT OF THE CONTRIBUTION OF THE VELCRO STRAPS USED BY THE SITE DURING THIS INCIDENT. THE OPERATOR MANUAL WARNS THE USER THAT DURING LOADING/UNLOADING OF THE PATIENT TO NEVER LEAVE THE PATIENT UNATTENDED/UNSUPERVISED ON THE TABLE AND RECOMMENDS THE USAGE OF VELCRO STRAPS. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED. BASED ON THIS ANALYSIS, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION CURRENTLY NOT AVAILABLE. INCIDENT DATE CURRENTLY NOT AVAILABLE. INITIAL REPORTER EMAIL WAS NOT PROVIDED. DEVICE MANUFACTURE DATE TO BE 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 THAT A PATIENT UNDERWENT A CATHETER INTERVENTION AND FELL OFF THE TABLE ONTO THE FLOOR. THE PATIENT WAS LIMITED BY A TABLE STRAP CONTROL MECHANISM AND SUPERVISED BY A NURSE AND TECHNICIAN. THE PATIENT ABRUPTLY SAT ON THE TABLE, AND THE VELCRO SAFETY STRAPS OPENED. THE PATIENT RECEIVED A HEAD INJURY AND RECEIVED MEDICAL INTERVENTION IMMEDIATELY. A FEW MONTHS LATER IN 2013, IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO MULTIPLE REASONS. THE PATIENT SUFFERED FROM CHRONIC SEVERE END-STAGE RENAL DISEASE (ESRD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631347 INNOVA 4100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS 230WV3

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death