BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2010266 · Received February 11, 2011

    Report

    Report Number
    3002158293-2011-00168
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 2, 2010
    Report Date
    February 10, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (OVER-VOLTAGE SET, CODE 110) HAS BEEN CONFIRMED. UPON EVALUATION, THE MONITOR GENERATED CODE 203, MEANING THE PREVIOUS FAULT TEST FAILED (WHICH CONFIRMED THE OVER-VOLTAGE FAULT). CODE 110 IS GENERATED WHEN THE VOLTAGE MEASURED ON THE CAPACITORS IS TOO LOW TO DELIVER A TREATMENT PULSE. THE CAUSE FOR THE OVER-VOLTAGE SET WAS THE RESULT OF A DEFECTIVE COMPONENT (Q1) ON THE COMPUTER ANALOG BOARD. Q1 IS A CURRENT CONTROLLING COMPONENT. THE ROOT CAUSE FOR THE DEFECTIVE Q1 CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY A RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A REVIEW OF A (B)(6) MALE PATIENT'S DOWNLOAD REVEALED AN OVER-VOLTAGE SET FLAG. ZOLL CUSTOMER SUPPORT CONTACTED THE PATIENT AND 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 52 YR