BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY CENTRAL MONITOR

    MDR report key: 970991 · Received December 27, 2007

    Report

    Report Number
    3023750-2007-00340
    Event Type
    Injury
    Date Received
    December 27, 2007
    Date of Event
    September 24, 2007
    Report Date
    November 29, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO NEED TO OBTAIN THE ACTUAL TRACKBALL USED BY THE CUSTOMER BECAUSE THE COMPLAINT IS NOT RELATED TO A MANUFACTURING DEFECT AND THERE WAS NO "DEVICE FAILURE" OR "DEVICE MALFUNCTION" TO INVESTIGATE. RESULTS: THERE IS NO EVIDENCE TO LEAD TO A CONCLUSION OF INCORRECT USE OF THE DEVICE. CONCLUSION: THE CONCLUSION IS THAT THE REPORTED COMPLAINT IS LIKELY THE RESULT OF THE WELL-KNOWN RISK ASSOCIATED WITH USE OF COMPUTER EQUIPMENT SUCH AS KEYBOARDS, MICE AND TRACKBALLS. THE CUSTOMER WILL BE ADVISED OF ADVICE PUBLISHED BY THE NATIONAL INSTITUTES OF HEALTH REGARDING STEPS THAT MAY BE HELPFUL IN MITIGATING WORKPLACE-RELATED CARPAL TUNNEL SYNDROME.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A HOSPITAL EMPLOYEE HAD EXPERIENCED A REPETITIVE STRESS INJURY OF THE RIGHT HAND (CARPAL TUNNEL) THAT WAS ATTRIBUTED TO THE USE OF A "TRACKBALL" COMPUTER ACCESSORY THAT IS USED IN CONJUNCTION WITH A CENTRAL PATIENT MONITORING SYSTEM. IT WAS REPORTED THAT THE EMPLOYEE HAD UNDERGONE SURGERY TO TREAT THE PROBLEM. IT WAS REPORTED THAT THE EMPLOYEE FILED A WORKMAN'S COMPENSATION CLAIM ON 9/24/2007. NOTE: NO PATIENT WAS INVOLVED. THE REPORTED INJURY WAS TO A STAFF INJURY. THE HOSPITAL DECLINED TO PROVIDE IDENTIFYING PARTICULARS OF THE STAFF MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITOR DSI WELCH ALLYN PROTOCOL, INC. ACUITY

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention