BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232997 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00250
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 19, 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) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY FAULT) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S DOWNLOAD REVEALED A HISTORY OF 0F40 BATTERY CHARGER FAULT FLAGS ON BATTERY PACK SN (B)(4). ZOLL CUSTOMER SUPPORT CONTACTED THE PT TO ISSUE A REPLACEMENT BATTERY PACK.

    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 65 YR