BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2799433 · Received October 16, 2012

    Report

    Report Number
    3008642652-2012-02622
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 8, 2012
    Report Date
    October 2, 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (CHECK THERAPY PAD MESSAGES AND ADJUST BELT OR CHECK BELT MESSAGES) HAVE BEEN CONFIRMED. UPON RECEIPT, THE ELECTRODE BELT FAILED THE THERAPY ELECTRODE RECOGNITION TEST AND WAS UNABLE TO DELIVER A TREATMENT. UPON EVALUATION, THE PULSE WIRES HAD POOR SOLDER JOINTS ON THE DISTRIBUTION NODE. THE CAUSE FOR THE BELT MESSAGES AND THE TEST FAILURE WAS THE POOR SOLDER JOINTS. THE ROOT CAUSE FOR THE DEFECTIVE SOLDER JOINTS CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED PULSE WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING EXCESSIVE CHECK THERAPY PAD MESSAGES AND ADJUST BELT OR CHECK BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 55 YR