BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3112144 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01100
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 17, 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 (CHARGER FAULT) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. UPON EVALUATION, THE Q1 TRANSISTOR WAS SHORTED IN THE BATTERY CIRCUIT ON THE BEDSIDE BOARD. THE CAUSE OF THE CHARGER FAULTS AND INABILITY TO CHARGE THE BATTERIES IS THE SHORTED Q1 TRANSISTOR. THE Q1 TRANSISTOR CONTROLS THE CURRENT FLOW TO THE BATTERY WHILE CHARGING. THE ROOT CAUSE OF THE SHORTED Q1 TRANSISTOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRANSISTOR. 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 THE HER CHARGER/MODEM WAS DISPLAYING A FAULT. THE PATIENT WAS PROVIDED WITH A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195646 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR