BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983263 · Received June 27, 2014

    Report

    Report Number
    3008642652-2014-01972
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER/MODEM WIL NOT CHARGE BATTERIES) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY CHARGER/MODEM WAS RESETTING. UPON EVALUATION, THERE WAS A BGA FAILURE ON U102 AND U105 ON THE COMPUTER/ANALOG (CA) BOARD. THE CAUSE OF THE CHARGER RESETS IS BGA FAILURE ON U102 AND U105 ON THE CA BOARD. THE FLASH MEMORY HAD AN INTERMITTENT BGA CONNECTION, WHICH WAS DISCOVERED THROUGH THE USE OF A FLASH MEMORY TEST. 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 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. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S CHARGER/MODEM WAS NOT CHARGING HIS BATTERIES. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377076 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR