BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES 6700B

    MDR report key: 1061907 · Received June 13, 2008

    Report

    Report Number
    1061907
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    February 28, 2008
    Report Date
    June 11, 2008
    Manufacturer
    SKYTRON
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS ADMITTED TO HOSPITAL IN 2008 FOR A PROLONGED SURGICAL PROCEDURE THAT LASTED 12 HOURS. AT APPROX 9-10 HOURS INTO THE PROCEDURE, IT WAS NOTED THAT THE LOWER EXTREMITY PORTION OF THE TABLE HAD BEEN INADVERTENTLY ADJUSTED IN THE FULL DOWN POSITION, SO THAT THE LOWER EXTREMITIES WERE BENT DOWN ALMOST 90 DEGREES AT THE KNEE. PT DEVELOPED A SERIOUS INJURY: A FOUR-COMPARTMENT SYNDROME OF THE RIGHT LEG. THREE DAYS LATER, HE UNDERWENT A FOUR-COMPARTMENT FASCIOTOMY OF THE RIGHT LEG WITH COMPLETE RELEASE OF THE SKIN AND FASCIA OF THE INVOLVED COMPARTMENTS. PT WAS DISCHARGED HOME TWELVE DAYS LATER. THIS EVENT WAS REPORTED TO DEPARTMENT OF HEALTH TWO WEEKS LATER. TWO MONTHS LATER, THE O.R. TEAM AND RISK MGMT IDENTIFIED THE ONE-TOUCH PENDANT CONTROL OF THE SURGICAL TABLE (SKYTRON HERCULES 6700B) TO BE AN ISSUE IN REGARD TO PT SAFETY FOR THE INADVERTENT CHANGE IN THE PT POSITION THAT CAUSED A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 6700B SURGICAL TABLE FQO SKYTRON 6700B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R