BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2011963 · Received February 14, 2011

    Report

    Report Number
    3002158293-2011-00173
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    October 31, 2010
    Report Date
    February 11, 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 BATTERY CHARGER (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (HUMMING NOISE/CHARGER FAULT) HAS BEEN CONFIRMED. UPON EVALUATION, THE CHARGER WAS FOUND TO HAVE A DEFECTIVE INTERNAL COMPONENT (U13). COMPONENT U13 IS AN 8-BIT CMOS FLASH MICRO-CONTROLLER LOCATED ON THE CHARGER PCA BOARD. THE ROOT CAUSE OF THE DEFECTIVE U13 CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY A RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PATIENT TO REPORT THAT THE PATIENT'S BATTERY CHARGER/MODEM WAS MAKING A HUMMING NOISE AND WOULD NOT SEND DATA. A REVIEW OF THE PATIENT'S FLAG FILES REVEALED A BATTERY CHARGER FAULT. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    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 53 YR