BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1861247 · Received October 1, 2010

    Report

    Report Number
    3002158293-2010-00995
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS DISCOVERED THAT THE BATTERY BACK HAD A DEFECTIVE CELL. THE ROOT CAUSE OF THE DEFECTIVE CELL CANNOT BE POSITIVELY IDENTIFIED. ONCE THE CELLS WERE REPLACED, THE BATTERY WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY. THE PT RECEIVED A REPLACEMENT BATTERY.

    Description of Event or Problem · 1

    DURING A REVIEW OF A (B)(6) MALE PT'S DOWNLOAD ZOLL LIFECOR CUSTOMER SUPPORT IDENTIFIED SEVERAL "BATTERY CHARGER FAULT" FLAGS IN THE DATA. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR