BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8744680 · Received June 28, 2019

    Report

    Report Number
    3008642652-2019-04870
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 20, 2019
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005012
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONNECTOR DAMAGED) HAS BEEN CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE CONNECTOR WAS PHYSICALLY DAMAGED AND THE ELECTRODE BELT WAS UNABLE TO SECURELY CONNECT TO A MONITOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED AN ELECTRODE BELT AND REPORTED THAT THE BELT HAD A DAMAGED CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536653 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1