BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2953993 · Received January 15, 2013

    Report

    Report Number
    3008642652-2013-00035
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    November 25, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 102) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS A DAMAGED TRACE AT THE NEGATIVE LEAD OF HIGH-VOLTAGE CAPACITOR C22 AND RESISTOR R45 WAS OPEN. THE CAUSE FOR THE CODE 102 IS THE OPEN R45. THE CAUSE FOR THE OPEN RESISTOR IS AN INTERMITTENT CONNECTION AT C22. THE CAUSE OF THE INTERMITTENT CONNECTION IS THE DAMAGED TRACE. THE ROOT CAUSE FOR THE DAMAGED TRACE COULD NOT BE POSITIVELY IDENTIFIED. IN ADDITION, THE FRONT RESPONSE BUTTON COVER WAS INTERMITTENT IN FUNCTION. THE ROOT CAUSE OF THE INTERMITTENT RESPONSE BUTTON IS PHYSICAL DAMAGE TO THE RESPONSE BUTTON. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRACE OR THE RESPONSE BUTTON. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 102 - CHARGE PROFILE FAULT. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21895 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR