BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2598795 · Received June 1, 2012

    Report

    Report Number
    3008642652-2012-01327
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 24, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT CHARGE BATTERY / CHARGER / MODEM DEFECTIVE) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS THERMAL DAMAGE TO THE Q1 TRANSISTOR. THE CAUSE FOR THE INABILITY TO CHARGE THE BATTERY AND DEFECTIVE CHARGER/MODEM MESSAGE IS THE THERMALLY DAMAGED TRANSISTOR (Q1). THE Q1 TRANSISTOR CONTROLS THE CURRENT FLOW TO THE BATTERY WHILE CHARGING. THE ROOT CAUSE OF THE DAMAGED Q1 TRANSISTOR CANNOT BE POSITIVELY IDENTIFIED. THE DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WILL NOT CHARGE) WAS CONFIRMED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE OR POWER ON A MONITOR. UPON EVALUATION, THE BATTERY CELLS HAD AN OUTPUT VOLTAGE OF 3.04V. THE CAUSE OF THE INABILITY TO CHARGE OR POWER ON A MONITOR IS THE LOW OUTPUT VOLTAGE. THE ROOT CAUSE OF THE LOW OUTPUT VOLTAGE IS THE DEFECTIVE CHARGER/MODEM. THE CHARGER/MODEM WAS UNABLE TO CHARGE THE BATTERY PACK. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRANSISTOR OR BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM AND BATTERY PACK. DEVICE MANUFACTURE DATE: CHARGER/MODEM: 04/2012. BATTERY PACK: 04/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER/MODEM WAS NOT CHARGING HIS BATTERY. WHEN A PATIENT SERVICE REPRESENTATIVE (PSR) VISITED THE PATIENT TO TROUBLESHOOT, THE PSR REPORTED THAT THE CHARGER/MODEM WAS DISPLAYING A RED CIRCLE WITH A SLASH, INDICATING THAT THE CHARGER/MODEM WAS DEFECTIVE. THE PATIENT WAS PROVIDED WITH A REPLACEMENT CHARGER/MODEM AND BATTERY PACK.

    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 48 YR