BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2860477 · Received November 5, 2012

    Report

    Report Number
    3008642652-2012-02882
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 26, 2012
    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 - CHARGE PROFILE FAULT) HAS BEEN CONFIRMED. UPON EVALUATION, HIGH VOLTAGE CAPACITORS C21 AND C22 WERE DETACHED FROM THE DEFIBRILLATOR BOARD. THE CAUSE OF THE CODE 102 - CHARGE PROFILE FAULTS IS THE DETACHED HIGH VOLTAGE CAPACITORS. THE CAUSE OF THE DETACHED HIGH VOLTAGE CAPACITORS IS BROKEN SOLDER CONNECTIONS AT THE CAPACITORS. THE CAUSE OF THE BROKEN CONNECTIONS IS LIKELY MECHANICAL SHOCK FROM PHYSICAL IMPACT. THE SOURCE OF THE PHYSICAL IMPACT CANNOT BE POSITIVELY DETERMINED. IN ADDITION, DURING TESTING , PLD COMPONENT U1003 WAS SHORTED. THE CAUSE OF THE SHORTED U1003 IS A MISDIRECTED TEST PULSE. THE CAUSE OF THE MISDIRECTED TEST PULSE IS THE DETACHED CAPACITORS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR