BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823649 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01281
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 15, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ZOLL LIFECOR 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 (ADD GEL/REPLACE BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF. THIS RESULTED IN AN INTERMITTENT CONNECTION BETWEEN THE CABLE AND DN. THE ROOT CAUSE OF THE PULLED CABLES COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    UPON REVIEW OF A (B)(6) MALE PATIENT'S FLAG FILES ZOLL CUSTOMER SUPPORT REPORTED ADD GEL/REPLACE BELT MESSAGES. THE PATIENT WAS CONTACTED AND ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261028 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR