BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823660 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01304
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 24, 2014
    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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE BELT FAILED INCOMING FUNCTIONAL TESTING. INVESTIGATION REVEALED THERE WAS AN OPEN PULSE WIRE IN THE DISTRIBUTION NODE (DN) TO ECG B CABLE. THE SOURCE OF THE OPEN PULSE WIRE WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY CAUSED BY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE LAST PATIENT 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. UPON SERVICING ELECTRODE BELT SN (B)(4), THE ELECTRODE BELT FAILED INCOMING FUNCTIONAL TESTING. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261504 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA