BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2821973 · Received October 1, 2012

    Report

    Report Number
    3008642652-2012-02598
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 1, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE ELECTRODE BELT FAILED THE PULSE LEAD HI POT TEST. UPON EVAL, WIRES INSIDE OF THE ECG-A TO ECG-B CABLE WERE DAMAGED. THE ROOT CAUSE OF THE DAMAGED INTERNAL WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING OF ELECTRODE BELT SN (B)(4), WHICH WAS RETURNED FOR NORMAL MAINTENANCE, THE ELECTRODE BELT FAILED THE PULSE LEAD HIGH POT TEST. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    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 NA