BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3150258 · Received May 29, 2013

    Report

    Report Number
    3008642652-2013-01396
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 20, 2013
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS RESETTING. THE CAUSE OF THE RESETS WAS AN INTERMITTENT CONNECTION AT BGA COMPONENT U500 (DSP). THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED BGA 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, AS THE MONITOR CASE WAS RETURNED WITH SIGNS OF DAMAGE. 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 ((B)(4)) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON (B)(4) 2012. IMPLEMENTATION BEGAN ON (B)(4) 2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER ON PROPERLY. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233670 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR