BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4210312 · Received August 8, 2014

    Report

    Report Number
    3008642652-2014-02400
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 9, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (CHARGER RESETTING) WAS CONFIRMED. AS RECEIVED, THE BATTERY CHARGER/MODEM WAS RESETTING. THE CAUSE OF THE BATTERY CHARGER NOT POWERING ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE COMPUTER/ANALOG BOARD. THE FLASH MEMORY HAD AN INTERMITTENT BGA CONNECTION. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED 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 THE SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE TO REDUCE THE PCA STRAIN ((B)(4)) WAS APPROVED BY FDA ON 04/16/2013. IMPLEMENTATION BEGAN ON 05/09/203. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT CHARGER/MODEM SN (B)(4) WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472948 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA