BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1963465 · Received January 12, 2011

    Report

    Report Number
    3002158293-2011-00040
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY/CHARGER 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.

    Description of Event or Problem · 1

    A REVIEW OF A (B)(6) MALE PT'S DOWNLOAD REVEALED SEVERAL BATTERY/CHARGER FAULTS. THE PT WAS CONTACTED AND ISSUED REPLACEMENT BATTERY PACKS AND A BATTERY CHARGER.

    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 74 YR