BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1781320 · Received July 28, 2010

    Report

    Report Number
    3002158293-2010-00788
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 28, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (NOT CHARGING BATTERIES) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HIS CHARGER WAS HOT TO THE TOUCH. THE PT ALSO REPORTED THAT THE CHARGER DID NOT APPEAR TO BE CHARGING THE BATTERIES. THE PT WAS PROVIDED WITH A REPLACEMENT 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 50 YR