BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3974891 · Received June 11, 2014

    Report

    Report Number
    3008642652-2014-01803
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 10, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE CAUSE FOR THE TEST FAILURE WAS ISOLATED TO BROKEN SOLDER CONNECTIONS WHERE THE GREEN, BLACK, RED, AND WHITE WIRES CONNECT TO THE ELECTRODE BELT DISTRIBUTION NODE PCA BOARD. THE ROOT CAUSE FOR THE BROKEN SOLDER CONNECTIONS AT THE WIRES COULD TO BE POSITIVELY IDENTIFIED. ON ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, ELECTRODE BELT SN (B)(4) FAILED INCOMING FUNCTIONALITY TESTING. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344405 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA