BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIGRAPHIC 6000 SURGICAL TABLE

    MDR report key: 8070829 · Received November 14, 2018

    Report

    Report Number
    1043572-2018-00089
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 14, 2018
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS INSTALLED AT THE CUSTOMER'S LOCATION IN 2006 AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE. THE FACILITY'S BIOMED DEPARTMENT IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE AND WAS INFORMED THAT CONTRARY TO THE REPORTED EVENT, THE TABLE DID NOT LOSE ALL POWER BUT RATHER, THE TABLE LOST PALM CONTROL FUNCTION. THE TECHNICIAN INSPECTED THE TABLE AND FOUND THE ROOT CAUSE OF THE EVENT TO BE A DAMAGED CONTROL CORD. THE CONTROL CORD SENDS A SIGNAL FROM THE PALM CONTROL TO THE SURGICAL TABLE ALLOWING THE TABLETOP TO TRANSLATE INTO THE DESIRED POSITION. AS THE CONTROL CORD WAS DAMAGED THE TABLE WAS UNABLE TO RESPOND TO ANY PALM CONTROL INPUTS CAUSING THE REPORTED EVENT TO OCCUR. THE FACILITY'S BIOMED DEPARTMENT REPAIRED THE DAMAGED CONTROL CORD, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING PROPERLY, AND RETURNED IT TO SERVICE. THE REPORTED EVENT CAN BE ATTRIBUTED TO IMPROPER ROUTINE MAINTENANCE. FACILITY PERSONNEL SHOULD INSPECT ALL ELECTRICAL CORDS AND CONNECTORS PRIOR TO USE AS STATED IN THE OPERATOR MANUAL. THE SURGIGRAPHIC 6000 SURGICAL TABLE OPERATOR MANUAL STATES (PG. 5-1), " ROUTINE MAINTENANCE: THE FOLLOWING ITEMS SHOULD BE INSPECTED WEEKLY...ELECTRICAL CORDS AND CONNECTORS: ENSURE ALL ELECTRICAL CORDS AND CONNECTORS ARE FREE OF LACERATIONS AND/OR DAMAGE." AND "CHECK ALL THE CONTROLS: ENSURE THE HAND CONTROL, FOOT CONTROL, AND PALM HANDLE CONTROL ARE ALL FULLY FUNCTIONAL." THE TECHNICIAN COUNSELED FACILITY PERSONNEL ON PROPER USE, OPERATION, AND MAINTENANCE OF THE TABLE. ADDITIONALLY, THE FACILITY WILL BE SCHEDULING STERIS TO CONDUCT PREVENTIVE MAINTENANCE ON THE REPORTED TABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE SURGIGRAPHIC 6000 SURGICAL TABLE LOST ALL POWER. FACILITY PERSONNEL MANUALLY MOVED THE PATIENT INTO THE DESIRED POSITION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907631 SURGIGRAPHIC 6000 SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1