BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983436 · Received June 27, 2014

    Report

    Report Number
    3008642652-2014-01983
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER FAULTS) HAS BEEN CONFIRMED. UPON INVESTIGATION OF THE BATTERY CHARGER/MODEM WAS UNABLE TO CHARGE BATTERY PACKS. THE CAUSE FOR THE FAILURE WAS ISOLATED TO CONTAMINATION ON THE BATTERY PCA BOARD. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    UPON REVIEW OF A (B)(6) FEMALE PATIENT'S FLAG FILES ZOLL CUSTOMER SUPPORT REPORTED BATTERY CHARGER FAULTS. THE PATIENT WAS CONTACTED AND ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377089 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR