BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESYNC ECG SYSTEM

    MDR report key: 966961 · Received December 14, 2007

    Report

    Report Number
    3003829651-2007-00002
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Date of Event
    December 15, 2006
    Report Date
    December 14, 2007
    Manufacturer
    LIFESYNC CORPORATION
    Product Code
    DRT
    Removal / Correction Number
    3003829651-01/26/07-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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 ATTEMPTED TO REMOVE LIFESYNC LEADWEAR DISPOSABLE MODEL NO. LS-222 LOT# C62297) FROM THE PACKAGING AND NOTED THAT THE LAMINATE HAD SEPARATED FROM THE V-LEAD. A HEALTH HAZARD EVAL 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. THIS INCIDENT WAS NOTED PRIOR TO USE ON THE PT, PREVENTING POTENTIAL HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESYNC ECG SYSTEM WIRELESS ECG SYSTEM DRT LIFESYNC CORPORATION LS-222 C6297

    Patients

    Seq Age Sex Outcome Treatment
    1 YR