BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY SYSTEM CONFIGURED WITH CART

    MDR report key: 1273116 · Received December 22, 2008

    Report

    Report Number
    2126317-2008-00005
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    December 2, 2008
    Manufacturer
    CARDINAL HEALTH 209
    Product Code
    GWE
    PMA / PMN Number
    K965065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAME TECHNICIAN ALSO USED ONE OF OUR EEG SYSTEMS (NICOLETONE VEEG). THIS SYSTEM IS ALSO IMPLICATED IN THIS SAME CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TECH IS SUFFERING FROM CARPAL TUNNEL SYNDROME (CTS). REPORT FROM CENTRA MEDICAL CENTER: "A CENTRA HEALTH SYSTEM EEG TECH HAS A WORKMAN'S COMP CASE FOR HAVING WORKED AT EEG SYSTEM FOR LONG HOURS. THE EEG MACHINE WORKSTATION IS NOT ERGONOMICALLY CORRECT. WHEN THE TECH SITS AT THE MACHINE THERE IS NO PLACE FOR THE TECH'S LEGS TO GO. IT IS VERY AWKWARD TO WORK AT THIS MACHINE. IT IS REPORTED THAT THE TECH WILL UNDERGO SURGERY FOR CTS. CENTRA WORKMAN'S COMP MANAGER ADVISED THAT THE EEG TECH IS SUFFERING FROM CTS DUE TO THE KEYBOARD BEING TOO HIGH FOR HER WHEN SHE SITS AT THE MACHINE. HE BELIEVES THAT THE CAUSE OF HER INJURIES IS THE INAPPROPRIATE HEIGHT OF THE KEYBOARD FOR HER SIZE AND STATURE. THE EFFECT IS THAT HER POSTURE IS NOT ERGONOMICALLY CORRECT WHILE WORKING AT THE MACHINE, RESULTING IN STRESS ON HER HANDS AND WRISTS AND PRESSURE ON THE MEDIAN NERVE. SQUEEZING AND IRRITATION OF THE MEDIAN NERVE CAN LEAD TO CTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SYSTEM CONFIGURED WITH CART ELECTROMYOGRAPH, DIAGNOSTIC GWE CARDINAL HEALTH 209 SYNERGY CART NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention