BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2953969 · Received January 15, 2013

    Report

    Report Number
    3008642652-2013-00117
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 10, 2013
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERIES ARE NOT CHARGING PROPERLY) WAS CONFIRMED. UPON EVALUATION, THERE WAS CONTAMINATION ON THE BATTERY BOARD INSIDE THE CHARGER/MODEM. THE CAUSE OF THE INABILITY TO PROPERLY CHARGE THE BATTERIES IS THE CONTAMINATION ON THE BATTERY BOARD. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS OF AN UNKNOWN CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER BATTERIES WERE NOT CHARGING PROPERLY. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21846 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR