BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRACE 2

    MDR report key: 1904026 · Received September 29, 2010

    Report

    Report Number
    1904026
    Date Received
    September 29, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSING STAFF NOTED RECENT ISSUES WITH LACK OF CONDUCTIVITY WITH CLEARTRACE ECG PATCHES USED FOR CARDIAC MONITORING. THIS PRODUCT IS USED ON ADULTS. THE PATIENT'S SKIN IS PREPPED WITH ALCOHOL WIPES PRIOR TO PLACING THE ELECTRODES. THE ELECTRODES ARE USED IN THE ER AND ARE FAILING RIGHT AFTER BEING APPLIED TO THE PATIENT AND DURING USE OVER TIME. THE ELECTRODES ARE STORED IN THE STOREROOM. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================CLINICAL ENGINEEERING INVESTIGATION NOTED PRODUCT IS PROBLEMATIC DUE TO DRYNESS. THE PRODUCT USED TO BE AVAILABLE WITH 5 ADULT ECG ELECTRODES PER PACKAGE, WHICH WOULD BE USED FOR 1 PATIENT FOR CARDIAC MONITORING. THE PRODUCT IS NOW PACKAGED IN LARGER QUANTITIES WITH 30 ELECTRODES. PATIENT CARDIAC SIGNAL IS BEING LOST DUE TO LOSS OF ELECTROLYTIC CARRYING CAPACITY DUE TO METHOD OF PACKAGING. THIS IS MORE PRONOUNCED IN PATIENTS WHO ARE SWEATING PROFUSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARTRACE 2 ELECTRODES, ECG DRX CONMED CORPORATION NA 1007122

    Patients

    Seq Age Sex Outcome Treatment
    1 *