BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 3100-IQ

    MDR report key: 6597730 · Received May 30, 2017

    Report

    Report Number
    9611343-2017-00008
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    May 2, 2016
    Report Date
    November 3, 2017
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K092004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR OF DEVICE NOT APPLICABLE. ROOM WAS NOT IN USE AND NO ONE WAS IN THE ROOM. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    BLOCK HAS BEEN UPDATED. 510(K): K092004. DEVICE MANUFACTURER DATE: 11/05/2010. NO INJURY WAS REPORTED. INVESTIGATION OF THIS EVENT WAS PERFORMED USING INFORMATION PROVIDED BY GEHC FIELD SERVICE ENGINEER AND SYSTEM PRE-INSTALLATION MANUAL. WHEN HE VISITED THE CUSTOMER SITE GE HEALTHCARE FIELD SERVICE ENGINEER NOTICED THAT THE GANTRY WAS VISUALLY LIFTED OFF THE FLOOR BY 7 MM. HE STOPPED THE SYSTEM FOR USAGE CITING RISK OF GANTRY FALL AND REMOVED THE GANTRY FROM THE FLOOR. HE OBSERVED THAT THE GROUT PAD WAS BROKEN AND THE CHEMICAL ANCHORS PULLED OUT FROM CONCRETE. THIS SYSTEM WAS INSTALLED ON (B)(6) 2011 BY GE HEALTHCARE FIELD SERVICE ENGINEER. CHEMICAL ANCHORS THAT WERE LOCALLY PROCURED WERE USED TO FIX THE GANTRY. DURING THE INSTALLATION, GE HEALTHCARE FIELD SERVICE ENGINEER DRILLED EXCESSIVE DIAMETER HOLES ON THE CONCRETE FOR THE ANCHORS. PRE-INSTALLATION MANUAL CONTAINS APPROPRIATE INSTALLATION KIT SPECIFICATION. IT ALSO INSTRUCTS TO INVOLVE STRUCTURAL ENGINEERS FOR INSTALLATION OF GANTRY TO THE FLOOR. IT WAS CONFIRMED THAT THIS INAPPROPRIATE INSTALLATION IS AN ISOLATED CASE. THE ROOT CAUSE OF THIS ISSUE IS AN INSTALLATION ERROR ISOLATED TO THIS SYSTEM SINCE INSTRUCTIONS WERE NOT FOLLOWED DURING INSTALLATION. GANTRY INSTALLATION INSTRUCTIONS HAVE BEEN REVIEWED AND FOUND TO BE APPROPRIATE, AND ALL NECESSARY TOOLS ARE ALSO PROVIDED WITH THE SYSTEM FOR CORRECT INSTALLATION. IT CANNOT BE DETERMINED WHY INITIAL GE HEALTHCARE FIELD SERVICE ENGINEER DID NOT USE ANCHORS PROVIDED WITH THE SYSTEM AND DRILLED EXCESSIVE DIAMETER HOLES SINCE HE LEFT GE HEALTHCARE IN BETWEEN. SYSTEM WAS CORRECTED ON (B)(6) 2017. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING A SERVICE INTERVENTION ON THE SYSTEM, GE HEALTHCARE FIELD SERVICE ENGINEER NOTICED THAT THE GROUT PAD ON WHICH THE C-ARM BASE PLATE IS FIXED WAS BROKEN. THIS CONDITION COULD LEAD TO A PARTIAL OR COMPLETE FALL OF THE ENTIRE GANTRY ASSEMBLY. THE GANTRY ASSEMBLY IS CURRENTLY INTACT AND DID NOT FALL. THERE WAS NO REPORT OF ANY INJURY AND NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378301 INNOVA 3100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1