BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823779 · Received May 2, 2014

    Report

    Report Number
    3008642652-2014-01358
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    March 17, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 (SQUEALING) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS ABLE TO PROPERLY DETECT AND TREAT. HOWEVER, UPON EVALUATION, THE MONITOR WAS ONLY ABLE TO POWER ON INTERMITTENTLY. THE CAUSE OF THE SQUEALING AND INTERMITTENT POWER IS LACK OF POWER FROM THE +1.8PXA, +3PXA, AND 2.7V LINES. THE CAUSE OF LACK OF POWER IS LIKELY AN INTERMITTENT CONNECTION AT 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. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE MONITOR WAS SQUEALING. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264049 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR