BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4001904 · Received July 3, 2014

    Report

    Report Number
    3008642652-2014-02094
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ZOLL MANUFACTURING 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 EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM, (WILL NOT POWER ON PROPERLY) WAS CONFIRMED. UPON EVAL, THE CHARGER/MODEM WOULD NOT POWER ON. THE CAUSE OF THE INABILITY TO POWER ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD SN (B)(4). THE FLASH MEMORY HAD AN INTERMITTENT BGA CONNECTION WHICH WAS DISCOVERED THROUGH THE USE OF A TARGET MEMORY TEST. THE INTERMITTENT SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE TO REDUCE THE PCA STRAIN ((B)(4)) WAS APPROVED BY FDA ON (B)(4) 2013. IMPLEMENTATION BEGAN ON (B)(4) 2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A TERRITORY MANAGER (TM) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PT TO REPORT THAT THE CHARGER/MODEM WOULD NOT POWER ON PROPERLY. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389304 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR