BEUDAMED
    FDA Adverse Event Summary report: N

    SKYTRON

    MDR report key: 2503489 · Received March 14, 2012

    Report

    Report Number
    1825014-2012-00002
    Date Received
    March 14, 2012
    Report Date
    March 13, 2012
    Manufacturer
    MIZUHO
    Product Code
    GDC
    Report Source
    Distributor report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN RESPONSE TO (B)(6)'S MDR # (B)(4). SKYTRON'S DISTRIBUTOR IN THE AREA, MAREC, INC. WENT TO (B)(6) TO EXAMINE THE 6500HD IN QUESTION. THE BIO-TECHNICIAN FOUND THE 17 YEAR OLD TABLE'S MINI-VALUES WERE ALL WORN AS WELL AS THE PENDANT CONTROL FACEPLATE WAS LOOSE WITH A JAMMED BUTTON. IT WAS ALSO NOTED THAT THE LEG/BACK SECTION RUBBER STOP FOR QUICK RELEASE LEVER WAS MISSING. THIS LEVER PREVENTS THE LEG/BACK SECTION FROM DISLODGING WHEN IN A 'DOWN' POSITION. SKYTRON'S RECOMMENDATIONS FOR PREVENTATIVE MAINTENANCE (ATTACHED) WHICH INCLUDES CHECKING THE MINI-VALVES EVERY 6 MONTHS FOR PROPER OPERATION. THE MINI-VALVES FUNCTION IS TO CONTROL THE FLOW OF THE HYDRAULIC FLUID. IF THE COMPONENTS ARE WORN, SPECIFICALLY THE CHECK VALVE, THERE IS NO 'STOP' FOR THE FLUID TO RETURN TO THE RESERVOIR WHICH WOULD CAUSE THE LEG/BACK SECTION TO DROP OR DRIFT. MAREC'S BIO-TECHNICIAN REPAIRED THE TABLE AT (B)(6)'S REQUEST AND UNDER (B)(6)'S PURCHASE ORDER. THE TABLE IS BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE GDC MIZUHO 6500HD *

    Patients

    Seq Age Sex Outcome Treatment
    1 *