BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1845030 · Received September 10, 2010

    Report

    Report Number
    3002158293-2010-00927
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ZOLL LIFECOR COPROATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS) HAS BEEN CONFIRMED. UPON RECEIPT, THE BATTERY CELLS WERE DEFECTIVE AND FOUND TO HAVE AN 0V OUTPUT. THE ROOT CAUSE OF THE DEFECTIVE CELLS CANNOT BE POSITIVELY IDENTIFIED. ONCE THE CELLS WERE REPLACED, THE BATTERY WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY. THE PATIENT RECEIVED A REPLACEMENT BATTERY.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE RECEIVED A MESSAGE THAT HIS ONE BATTERY PACK MAY HAVE A PROBLEM. THE PATIENT WAS PROVIDED WITH A BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR