BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843870 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02813
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 22, 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. UPON INVESTIGATION THE ELECTRODE BELT FAILED A HI-POT TEST DUE TO A CRIMPED GREEN WIRE (BELT DISCHARGE) IN ECG "B." THE ROOT CAUSE FOR THE DAMAGED WIRE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    WHILE INVESTIGATING AN (B)(6) FEMALE PATIENT'S ELECTRODE BELT FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE ELECTRODE BELT FAILED A HI-POT TEST. 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 81 YR