BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4214782 · Received October 1, 2014

    Report

    Report Number
    3008642652-2014-03038
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL ECG ELECTRODES) HAS BEEN CONFIRMED. AS RECEIVED, THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO REAR THERAPY PAD (TE) WAS PULLED FROM THE STRAIN RELIEF, BREAKING THE JOINT CONNECTING THE REAR PULSE WIRES. THE CAUSE FOR THE FAILURE WAS ISOLATED TO THE PULLED DN TO REAR TE CABLE. THE ROOT CAUSE FOR THE DAMAGED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610491 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA