BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3961228 · Received May 28, 2014

    Report

    Report Number
    3008642652-2014-01601
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 20, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (WILL NOT RECOGNIZE BATTERY) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO CHARGE A BATTERY. THE CAUSE FOR THE INABILITY TO CHARGE WAS ISOLATED TO A SHORTED U13 CMOS FLASH MICRO-CONTROLLER. THE ROOT CAUSE FOR THE SHORTED U13 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED U13 COMPONENT. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS CHARGER WOULD NOT RECOGNIZE HIS BATTERY PACK. THE PATIENT WAS PROVIDED WITH A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314690 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR