BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1811236 · Received August 11, 2010

    Report

    Report Number
    3002158293-2010-00827
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: MONITOR SN (B)(4). BATTERY SN (B)(4). BATTERY SN (B)(4). DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF MONITOR SN (B)(4), AND BATTERIES SN (B)(4) AND (B)(4) HAVE NOT YET BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS) 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 MONITOR AND BATTERIES. THE PT RECEIVED A REPLACEMENT MONITOR AND TWO REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT'S SISTER CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT RECEIVED AN ERROR SAYING THAT THERE MIGHT BE A PROBLEM WITH THE BATTERY. THE ERROR OCCURRED WITH BOTH OF THE PT'S BATTERIES. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR AND TWO BATTERY PACKS.

    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