BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6000914 · Received October 5, 2016

    Report

    Report Number
    3008642652-2016-07234
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    August 30, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (DAMAGED THERAPY ELECTRODE PAD/SENSING PAD) WAS CONFIRMED. AS RECEIVED, THE ELECTRODE BELT FAILED INCOMING TESTING. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO REAR THERAPY PAD (TE) WAS PULLED FROM THE STRAIN RELIEF, DISCONNECTING WIRES IN THE DN. THE CAUSE OF THE TEST FAILURE WAS THE PULLED DN TO REAR TE CABLE. THE ROOT CAUSE FOR THE PULLED CABLE IS EXCESSIVE FORCE. ADDITIONALLY, THE CONNECTOR ON THE TRUNK CABLE WAS CRACKED. THE ROOT CAUSE FOR THE PULLED CABLES IS EXCESSIVE FORCE. THE ROOT CAUSE FOR THE CRACKED TRUNK CONNECTOR WAS PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED A DAMAGED THERAPY ELECTRODE PAD/SENSING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651420 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1