BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 6908951 · Received October 2, 2017

    Report

    Report Number
    1825014-2017-00006
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    August 23, 2017
    Report Date
    October 2, 2017
    Manufacturer
    MIZUHO CORPORATION
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THIS IS A RESPONSE TO BAXTER REGIONAL REPORT NUMBER MW5071956. UPON EVALUATION OF THE INCIDENT, SKYTRON DETERMINED THAT THE FACILITY DID NOT FOLLOW INSTRUCTIONS IN THE OWNERS MANUAL REGARDING EXTREME POSITIONING. THE MANUAL STATES "THE EXTREME POSITIONING CAPABILITIES OF THE 3600B ULTRASLIDE TABLE REQUIRES SPECIAL ATTENTION FOR POSSIBLE INTERFERENCE POINTS WHEN USING MULTIPLE FUNCTION POSITIONING. AS WITH THE OPERATION OF ANY SURGICAL TABLE, A CERTAIN AMOUNT OF CARE SHOULD BE EXERCISED TO POSITION THE PATIENT SAFETY." THERE IS ALSO A CAUTION THAT STATES "THE COMBINATION OF MINIMUM ELEVATION (TOP ALL THE WAY DOWN), EXTREME TRENDELENBURG POSITIONING AND TOP SLIDE FUNCTION MAY ALLOW THE BACK SECTION TO COLLIDE WITH THE BASE OR FLOOR.". THE FACILITY WAS INFORMED OF THESE STATEMENTS FROM A LOCAL SKYTRON REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688323 SKYTRON 3600B FQO MIZUHO CORPORATION 3600B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention