BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983454 · Received June 27, 2014

    Report

    Report Number
    3008642652-2014-01995
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 SUMMARY: ELECTRODE BELT SN (B)(4) HAS BEEN EVALUATED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WOULD NOT SECURELY CONNECT WITH THE MONITOR. THE CAUSE FOR THE INABILITY TO PROPERLY CONNECT WITH THE MONITOR IS A DEFECTIVE TRUNK CABLE CONNECTOR. THE ROOT CAUSE HAS NOT BEEN POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    WHILE EVALUATING THE ELECTRODE BELT FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS FOUND. THE PATIENT'S ELECTRODE BELT TRUNK CABLE CONNECTOR WAS UNABLE TO SECURELY LATCH TO A MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377002 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR