BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-TRACE 535 FOAM ELECTRODES

    MDR report key: 1232363 · Received November 2, 2008

    Report

    Report Number
    1232363
    Event Type
    Malfunction
    Date Received
    November 2, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 2, 2008
    Manufacturer
    COVIDIEN KENDALL
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT NEEDED URGENT CARDIAC MONITORING. LEADS APPLIED BY RN. NO READING OBTAINED; DEFIBRILLATOR/MONITOR HAD BEEN CHECKED AND WAS FUNCTIONAL EARLIER IN THE SHIFT. DURING TROUBLESHOOTING, IT WAS NOTED THAT ONE OF THE ELECTRODE PADS HAD NO GEL IN IT-IT WAS NEW OUT OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TRACE 535 FOAM ELECTRODES ELECTRODES, ECG, MONITORING DRX COVIDIEN KENDALL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR