BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4250210 · Received November 6, 2014

    Report

    Report Number
    3008642652-2014-03703
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 11, 2014
    Report Date
    November 5, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (THERAPY ELECTRODE NON-FUNCTIONAL) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN PULSE WIRE BETWEEN THE FRONT TE AND ECG A. THE ROOT CAUSE FOR THE OPEN PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) TO REPORT THAT THE THERAPY ELECTRODES WERE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714958 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1