BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061707 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00876
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 28, 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK TE MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THE CABLE CONNECTING THE REAR THERAPY ELECTRODE (TE) AND THE DISTRIBUTION NODE (DN) WAS PULLED FROM THE DN STRAIN RELIEF, DAMAGING INTERNAL WIRES. IN ADDITION, THE TRUNK CABLE CONNECTOR WAS CRACKED. THE CAUSE FOR THE CHECK TE MESSAGES IS THE DAMAGED WIRES INSIDE THE CABLE CONNECTING THE REAR TE AND THE DN. THE CAUSE FOR THE DAMAGED WIRES IS THE DETACHED CABLE. THE ROOT CAUSE OF THE DAMAGED CABLE AND WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. THE ROOT CAUSE FOR THE CRACKED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT CHECK TE (THERAPY ELECTRODE) ALARMS. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130023 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR