BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    256 CHANNEL GES 400 CLINICAL EEG SYSTEM WITH IMAC

    MDR report key: 7574942 · Received June 6, 2018

    Report

    Report Number
    3001090553-2018-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 9, 2018
    Manufacturer
    ELECTRICAL GEODESICS, INC.
    Product Code
    GWQ
    UDI-DI
    00863003000305
    PMA / PMN Number
    K131882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION RESULTS, THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE WELDS WOULD FAIL IN SUCH A MANNER, WITH THE TUBE SUPPORTING THE CAMERA, TO RESULT IN A FREE-FALLING CAMERA AND STRIKING A PATIENT. THE REPORTED RATE OF OCCURRENCE BASED ON THE FAILURES OF WELDS WITHIN THE POPULATION OF CARTS PRODUCED BY THE MANUFACTURER IS CALCULATED TO BE 0.0014 (3 KNOWN WELD FAILURE EVENTS OUT OF 2,078 CARTS). THE HAZARD LIKELIHOOD IS CALCULATED TO BE "REMOTE". THE COMPLAINT AND TEST DATA INDICATE THAT UNDER AND ACTIVE LOAD, SUCH AS MANIPULATION BY SEVERAL OPERATORS, THE WELDS MAY BREAK CAUSING THE POLE TO LEAN AND THEREFORE FAIL SAFELY, WITHOUT FALLING OVER AND IMPACTING A PATIENT. THE INVESTIGATION CONCLUDES THERE HAVE BEEN NO COMPLAINTS OR TEST RESULTS INDICATING SPONTANEOUS FAILURE OF THE POLE SUPPORTS; HENCE, IT IS IMPROBABLE THAT THE POLE SUPPORTS WILL FAIL ALLOWING A CAMERA TO FALL ONTO A PATIENT.

    Description of Event or Problem · 0

    THE GES 400 SYSTEM WAS USED IN AN EPILEPSY MONITORING UNIT (EMU) ROOM TO RECORD A PATIENT'S EEG. THE GES 400 CART WAS POSITIONED NEXT TO THE PATIENT'S BED WITH THE CAMERA PARAPET POSITIONED ABOVE THE PATIENT'S BED. THERE WERE TWO EMU STAFF AT THE CART, WITH THE LEAD TECHNICIAN TRAINING A NEW TECHNICIAN. IT WAS REPORTED THAT WHILE THE TECHNICIANS WERE ADJUSTING THE CAMERA POLE TO A HIGHER POSITION THEY HEARD A CRACK/NOISE AT WHICH TIME THEY NOTICED THAT THE CAMERA POLE HAD STARTED TO HAVE A PARTIAL LEAN FROM THE BASE AWAY FROM THE CART. THE LEAD TECHNICIAN ASKED THE TECHNICIAN-IN-TRAINING TO HOLD THE POLE TO SUPPORT THE CAMERA, WHILE SHE WENT TO GET THE EEG DEPARTMENT MANAGER. THE UNIT MANAGER AND THE TECHNICIANS INVESTIGATED THE BASE OF THE CAMERA PARAPET AND DECIDED TO COMPLETELY REMOVE THE CAMERA POLE FROM THE CART BY BREAKING THE REMAINING WELDS. THE SEPARATION WAS CONTROLLED AND NO DEBRIS WERE RELEASED. THERE WAS NO REPORT OF PATIENT OR USER INJURY.

    Description of Event or Problem · 1

    THE GES 400 SYSTEM WAS BEING USED IN AN EMU ROOM TO RECORD A PATIENT'S EEG. THE GES 400 CART WAS POSITIONED NEXT TO THE PATIENT 'S BED WITH THE CAMERA PARAPET POSITIONED ABOVE THE PATIENT. THERE WERE TWO EMU STAFF NEAR THE CART, WITH THE LEAD TECHNICIAN TRAINING A NEW TECHNICIAN. THE TECHNICIANS WERE ADJUSTING THE CAMERA POLE HIGHER (PRESSED BUTTON TO RAISE THE POLE) WHEN THEY NOTICED THAT THE CAMERA POLE BECAME DETACHED FROM THE BASE AS IT WAS BEING RAISED. THE LEAD TECHNICIAN ASKED THE NEW TECHNICIAN TO HOLD THE POLE TO SUPPORT THE CAMERA WHILE SHE WENT TO GET THE EEG DEPARTMENT MANAGER. WHEN THE MANAGER CAME TO THE ROOM, THEY ASSESSED THE SITUATION AND FURTHER MOVEMENT CAUSED THE CAMERA POLE TO MECHANICALLY DETACH FROM THE CART AS IT WAS BEING HELD. THE CAMERA POLE REMAINED CAPTIVE TO THE CART BY WAY OF THE CAMERA SIGNAL CABLE INSIDE OF THE POLE. THE SEPARATION WAS CONTROLLED AND NO DEBRIS WAS RELEASED; THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ALLEGATION OF PATIENT OR USER INJURY. THE EEG CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416033 256 CHANNEL GES 400 CLINICAL EEG SYSTEM WITH IMAC GES 400 GWQ ELECTRICAL GEODESICS, INC. ZZ-01 3/29/16 8:29 00863003000305

    Patients

    Seq Age Sex Outcome Treatment
    1