BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072317 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00918
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 2, 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 (WILL NOT RECOGNIZE A BATTERY PACK) HAS BEEN CONFIRMED. UPON EVALUATION, COMPONENTS U13 (8-BIT CMOS FLASH MICROCONTROLLER) AND Y1 (10 MHZ SMD CRYSTAL) WERE DEFECTIVE. THE CAUSE OF THE INABILITY TO RECOGNIZE THE BATTERIES WAS THE DEFECTIVE U13 AND Y1. THE ROOT CAUSE OF THE DEFECTIVE COMPONENTS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER CHARGER/MODEM WOULD NOT RECOGNIZE HER BATTERIES. THE PT WAS PROVIDED WITH A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142028 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR