BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961188 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00161
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SQUEALING / DOES NOT POWER ON PROPERLY) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS RESETTING. THE CAUSE OF THE SQUEALING AND INABILITY TO POWER ON PROPERLY WAS AN INTERMITTENT CONNECTION AT BGA COMPONENT U500 (DSP) ON CA BOARD SN (B)(4). 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. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. (B)(4). NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SQUEALING SOUND. WHILE ATTEMPTING TO TROUBLESHOOT, THE PT'S NURSE ALSO REPORTED THAT THE MONITOR WOULD NOT POWER ON PROPERLY. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27473 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR