BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2243635 · Received July 27, 2011

    Report

    Report Number
    3008642652-2011-00306
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 27, 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 OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. THE CAUSE FOR THE SERVICE CODE 204 IS DUE TO MULTIPLE COMPONENT FAILURES. UPON EVALUATION IT WAS DISCOVERED THAT CAPACITOR C2 AND CAPACITOR C5 AND U1 HAD FAILED IN ECG NODES A AND B. IN ADDITION, BELT NODE PCA COMPONENTS Q702 (NPN SMALL SIGNAL TRANSISTOR) AND U726 (VOLTAGE REFERENCE) IN THE DISTRIBUTION NODE HAD ALSO FAILED. THE ROOT CAUSE FOR THE COMPONENT FAILURES CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT MULTIPLE SERVICE CODE 204 MESSAGES. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    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 58 YR