BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843806 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02773
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 17, 2012
    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 EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM HAS BEEN CONFIRMED. THE CAUSE FOR THE DEFECTIVE BATTERY CHARGER/MODEM IS A THERMALLY DAMAGED TRANSISTOR (Q1). THE Q1 TRANSISTOR CONTROLS THE CURRENT FLOW TO THE BATTERY WHILE CHARGING. THE ROOT CAUSE OF THE THERMALLY DAMAGED Q1 WAS UNABLE TO BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRANSISTOR. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A PT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT¿S CHARGER/MODEM WAS NOT WORKING PROPERLY. THE PT WAS PROVIDED WITH A REPLACEMENT CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR