BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2823707 · Received October 10, 2012

    Report

    Report Number
    3008642652-2012-02708
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ZOLL LIFECOR 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) HAS BEEN COMPLETED. AS RECEIVED, THE ELECTRODE BELT FAILED THE TE RECOGNITION TEST. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE AND FRONT THERAPY ELECTRODE WAS FOUND TO BE PULLED FROM THE STRAIN RELIEF. THE ROOT CAUSE FOR THE DAMAGED CABLE WAS UNABLE TO BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE LAST PATIENT TO USE DEVICE DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    UPON INVESTIGATION OF ELECTRODE BELT SN (B)(4), WHICH WAS RETURNED FOR AN UNRELATED NONCONFORMANCE, THE ELECTRODE BELT FAILED THE TE RECOGNITION TEST. THE LAST PATIENT TO USE THE DEVICE DID NOT REPORT ANY DEFICIENCIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR