BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232942 · Received July 21, 2011

    Report

    Report Number
    3008642652-2011-00265
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) HAS BEEN CONFIRMED. UPON EVALUATION, THE CA BOARD HAD FAILURES AT COMPONENTS V6000 AND L610 WHICH PRODUCED HEAT. THE V600 COMPONENT IS A TRANSIENT VOLTAGE SUPPRESSOR THAT PROTECTS THE UNIT FROM SUDDEN OVER-VOLTAGES. THE L610 COMPONENT FILTERS OUT ELECTROMAGNETIC INTERFERENCES FROM OUTSIDE SOURCES. THE HEAT FROM THE FAILURE ALSO LED TO DAMAGE ON THE OUTER CASING OF CAPACITOR C20. THE ROOT CAUSE FOR THE FAILURE CANNOT BE POSITIVELY IDENTIFIED. THIS IS AN UNUSUAL EVENT. NO ADVERSE EVENT RESULTED FROM THE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WILL NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    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 59 YR