BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GES 400

    MDR report key: 9195123 · Received October 15, 2019

    Report

    Report Number
    3001090553-2019-00001
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 15, 2019
    Manufacturer
    ELECTRICAL GEODESICS, INC.
    Product Code
    GWQ
    UDI-DI
    00863003000305
    PMA / PMN Number
    K131882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUS MDR 3001090553-2018-00001 WAS SUBMITTED FOR A SIMILAR FAILURE. NO INJURY WAS REPORTED IN THE PREVIOUS MDR HOWEVER THE POTENTIAL FOR INJURY WAS IDENTIFIED. FOR THIS MDR REPORT, THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER HOWEVER THREE HIGH RESOLUTION PHOTOS WERE PROVIDED BY THE CUSTOMER. THESE PHOTOS CLEARLY SHOW THE BOTTOM PORTION OF THE CAMERA POLE AND THE MOUNT. THE PHOTOS READILY SHOW THE CLEAN BREAKAGE OF ALL FOUR WELDS. NO DEFORMATION OR MISSING MATERIAL WAS NOTED. INTERNAL REVIEW CONFIRMED THIS SYSTEM WAS FITTED WITH A CAMERA POLE FROM A PREVIOUSLY REVIEWED LOT OF CAMERA POLES RECEIVED FROM A 3RD PARTY VENDOR, ZZ-01 3/29/16 8:29. SCAR 18-2004 WAS ISSUED AND THE VENDOR RESPONDED WITH THE ROOT CAUSE AS A LACK OF WELD PENETRATION DUE TO EITHER INCORRECT EQUIPMENT SETTINGS OR OPERATOR TECHNIQUE. TO ADDRESS THIS ROOT CAUSE, THE VENDOR ENACTED THE FOLLOWING CORRECTIVE ACTIONS: OPERATOR WELD CERTIFICATION UPON HIRE & ANNUAL RECERTIFICATION; INTRODUCTION OF EQUIPMENT SETTINGS VERIFICATION FOR EACH RUN VIA A PULL TEST OF WELDED TEST PLATE AND INSTITUTION OF A 100% VISUAL INSPECTION BY QC INSPECTORS. NO ADDITIONAL LOTS OF CAMERA POLES WERE OBTAINED FROM THIS VENDOR. A REDESIGN OF THE GES 400 CART W/CAMERA POLE HAS BEEN COMPLETED VIA A DIFFERENT VENDOR IN (B)(6) 2019.

    Description of Event or Problem · 1

    THE GES400 SYSTEM WAS BEING TRANSPORTED VIA THE GES400 CART ALONG THE CORRIDOR WHEN THE CLINICIAN WAS MOVING TO THE CLINIC'S MONITORING UNIT. DURING THIS TRANSPORT, THE CAMERA POLE DETACHED FROM THE CART AND FELL TO THE GROUND IMMEDIATELY. THERE WAS NO SHRAPNEL AS THE BREAK WAS CLEAN FROM THE WELD. THE GES400 SYSTEM WAS NOT IN USE AT THE TIME OF THE CAMERA POLE MECHANICAL FAILURE. THERE WAS NO ALLEGATION OF PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986486 GES 400 256 CHANNEL GES400 CLINICAL EEG SYSTEM W/IMAC GWQ ELECTRICAL GEODESICS, INC. ZZ-01 03/29/16 8:29 00863003000305

    Patients

    Seq Age Sex Outcome Treatment
    1