BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3974868 · Received June 11, 2014

    Report

    Report Number
    3008642652-2014-01752
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ZOLL LIFE 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: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) WAS COMPLETED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE TO THE REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF, DAMAGING WIRES. THE ROOT CAUSE FOR THE STRAINED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO 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) FAILURE INCOMING FUNCTIONALITY TESTING. THE LAST PATIENT OT USE THIS ELECTRODE BELT DID NOT REPROT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343836 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFE CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA