BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2974594 · Received January 29, 2013

    Report

    Report Number
    3008642652-2013-00208
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION PINS IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WERE BENT. THE ROOT CAUSE OF THE BENT PINS WAS UNABLE TO BE POSITIVELY IDENTIFIED, BUT WAS LIKELY EXCESSIVE FORCE APPLIED WHEN THE BELT WAS MATED WITH THE MONITOR. NO ADVERSE EVENT OCCURRED DUE TO THE BENT PINS IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 204 - BELT/MONITOR UNUSABLE. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39910 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR