BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2941672 · Received December 21, 2012

    Report

    Report Number
    3008642652-2012-03307
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ZOLL LIFECOR CORP.
    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 (EXPOSED WIRE) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF, EXPOSING WIRES. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE STRAINED CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A WIRE WAS EXPOSED ON THE PATIENT'S ELECTRODE BELT. 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 CORP. WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR