BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESYNC ECG SYSTEM

    MDR report key: 967030 · Received December 18, 2007

    Report

    Report Number
    3003829651-2007-00001
    Event Type
    Malfunction
    Date Received
    December 18, 2007
    Date of Event
    January 3, 2007
    Report Date
    December 14, 2007
    Manufacturer
    LIFESYNC CORPORATION
    Product Code
    DRT
    Removal / Correction Number
    3003829651-01/26/2007-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION OF THE ISSUE, A POSSIBLE ROOT CAUSE WAS DETERMINED. THE TOP INSULATING (PET) LAYER CAN SEPARATE AND TEAR FROM THE UNDERLYING CIRCUIT LAYER WHEN TRYING TO PULL THE V-LEAD AWAY FROM ITS PERFORATIONS. ALL LOTS ASSOCIATED WITH THIS FAILURE MODE WERE REMOVED FROM THE FIELD UNDER RECALL. NO HARM WAS CAUSED TO THE PT AS A RESULT OF THIS INCIDENT. HOWEVER, UPON RETROSPECTIVE REVIEW OF THIS ISSUE, THE POTENTIAL FOR HARM WAS IDENTIFIED AND THE INCIDENT HAS BEEN DEEMED REPORTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THEY PLACED LIFESYNC LEADWEAR DISPOSABLE MODEL NO. LS-223 LOT# 002308 S ON THE PT AND DID NOT OBSERVE AN ECG SIGNAL. UPON REVIEW OF THE LEADWEAR, THE CUSTOMER NOTED THAT THE LAMINATE HAD SEPARATED FROM THE V-LEAD WHILE REMOVING THE LEADWEAR FROM THE PACKAGE. A HEALTH HAZARD EVALUATION WAS PERFORMED REGARDING THE FAILURE MODE. IT WAS DETERMINED THAT A TEAR IN THE LAMINATE COULD EXPOSE THE DIELECTRIC LAYER, CAUSING A "BREAK" IN THE SILVER INK. IF DEFIBRILLATION WAS PERFORMED AFTER SUCH A DE-LAMINATION, IT COULD INTRODUCE HIGHER THAN NORMAL HEAT TO THE SKIN, POSSIBLY LEADING TO BURNS, AND MAY COMPROMISE THE EFFICACY OF THE DEFIBRILLATION. NO HARM WAS CAUSED TO THE PT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESYNC ECG SYSTEM WIRELESS ECG SYSTEM DRT LIFESYNC CORPORATION LS-223 002308 S

    Patients

    Seq Age Sex Outcome Treatment
    1 YR