BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1972692 · Received January 20, 2011

    Report

    Report Number
    3002158293-2011-00064
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    September 24, 2010
    Report Date
    January 17, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. UPON EVAL, DEFECTIVE CELLS WERE FOUND IN THE BATTERY PACK. THE CAUSE OF THE BATTERY NOT CHARGING PROPERLY WAS FAULTY CELLS WITHIN THE BATTERY PACK. THE ROOT CAUSE OF THE FAULTY CELLS APPEARS TO BE RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT WAS INFORMED BY SUPPORT RETURNS THAT A BATTERY PACK RETURNED TO ZOLL DUE TO PHYSICAL DAMAGE.

    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 NA