BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESYNC ECG SYSTEM

    MDR report key: 965631 · Received December 14, 2007

    Report

    Report Number
    3003829651-2007-00006
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Date of Event
    November 20, 2007
    Report Date
    December 14, 2007
    Manufacturer
    LIFESYNC CORPORATION
    Product Code
    DRT
    Removal / Correction Number
    3003829651-12/13/2007-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT ISSUE WAS CONFIRMED IN HOUSE. A POSSIBLE ROOT CAUSE WAS DETERMINED. THE REGISTRY OF THE SILVER TRACE ON THE LARGE SIZED LEADWEAR IS SHIFTED, RESULTING IN A FAILURE TO MAKE CONTACT WITH THE BOURNES CLIP PINS OF THE 12 LEAD ADAPTORS LEADING TO A V-LEAD FAILURE. NO HARM WAS CAUSED TO THE PT AS A RESULT OF THIS INCIDENT. THE POTENTIAL FOR HARM WAS IDENTIFIED AND THE INCIDENT HAS BEEN DEEMED REPORTABLE.

    Description of Event or Problem · 1

    A CUSTOMER INDICATED THAT THEY HAD ATTEMPTED TO PREPARE A PT FOR 12 LEAD ECG MONITORING WITH LARGE SIZED LIFESYNC LEADWEAR, USED IN CONJUNCTION WITH A LIFESYNC 12 LEAD CABLE ADAPTOR. PT INFO WAS NOT PROVIDED. THE CUSTOMER INDICATED THAT THEY OBSERVED AN OUT OF BOX V-LEAD FAILURE. THE CUSTOMER REMOVED THE LEADWEAR FROM THE PT, AND REPLACED THE FAILED LEADWEAR WITH A UNIT FROM THE SAME LOT. THE SECOND UNIT FUNCTIONED APPROPRIATELY. LIFESYNC CORPORATION REVIEWED THE EVENTS AND DETERMINED THAT A V-LEAD FAILURE DURING AN EMERGENCY SITUATION COULD LEAD TO A DELAY IN TREATMENT, WHICH CAN RESULT IN PERMANENT IMPAIRMENT TO THE PT. 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-202 05 03

    Patients

    Seq Age Sex Outcome Treatment
    1 YR