BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4080964 · Received July 9, 2014

    Report

    Report Number
    3008642652-2014-02139
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 31, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 THERAPY ELECTRODE MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN INTERMITTENT SOLDER CONNECTION ON THE TAB OF CONNECTOR J2 INSIDE THE FRONT THERAPY ELECTRODE. THE ROOT CAUSE FOR THE INTERMITTENT SOLDER CONNECTION WAS AN ASSEMBLY ERROR. A CORRECTIVE ACTION HAS BEEN INITIATED. NO ADVERSE EVENT RESULTED FROM THE INTERMITTENT SOLDER CONNECTION. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE HUSBAND OF A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS RECEIVING FREQUENT CHECK THERAPY ELECTRODE MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400871 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR