BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMLINE

    MDR report key: 2997464 · Received February 22, 2013

    Report

    Report Number
    2997464
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 22, 2013
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLOOD PRESSURE (BP) CUFFS USED IN SURGERY CAUSED "CRUSH INJURY" TO UPPER EXTREMITY RESULTING IN NUMBNESS, LOCAL SWELLING AND PAIN, AS WELL AS RHABDOMYOLYSIS SYMPTOMS AND KIDNEY DYSFUNCTION. BP CUFF WAS USED ON THIS EXTREMITY FOR APPROXIMATELY 3 HOURS. ANESTHESIOLOGISTS BELIEVE THAT THIS CUFF IS LESS "COMPLIANT" TO THE PATIENT'S ANATOMY, AND WHEN CYCLING EVERY 5 MINUTES FOR INTRAOPERATIVE MONITORING, THIS CAUSED INJURY TO THE ARM FROM EXTENSIVE USE AND RESTRICTION. THEY HAVE NEVER HAD THIS ISSUE WITH THE REUSABLE CUFFS USED BEFORE JANUARY OF THIS YEAR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DA VINCI PROSTATECTOMYDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78428 TRIMLINE BLOOD PRESSURE CUFF DXQ WELCH ALLYN, INC. 39048 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R NO OTHER THERAPIES