BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3944529 · Received May 9, 2014

    Report

    Report Number
    3008642652-2014-01411
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A DAMAGED TRUNK CABLE CONNECTOR. THE CONNECTOR WAS CRACKED, AND THE WHITE DRIVEN GROUND WIRE WAS OPEN IN THE CONNECTOR. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. 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 THE PATIENT WAS RECEIVING FREQUENT CHECK BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281147 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR