BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3842547 · Received February 21, 2014

    Report

    Report Number
    3008642652-2014-00534
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 17, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE MONITOR NOT POWERING ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD. THE FLASH MEMORY HAD AN INTERMITTENT CONNECTION, WHICH WAS DISCOVERED THROUGH THE USE OF A TARGET 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 WAS APPROVED BY FDA ON (B)(4) 2012. IMPLEMENTATION BEGAN (B)(4) 2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DURING SERVICING OF MONITOR SN (B)(4), WHICH WAS RETURNED FOR AN UNRELATED REASON, THE MONITOR WOULD NOT POWER UP. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109045 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR