BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3842526 · Received February 21, 2014

    Report

    Report Number
    3008642652-2014-00589
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 22, 2013
    Report Date
    February 20, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR RESETS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS CONTINUALLY RESETTING. THE CAUSE OF THE RESETS WAS ISOLATED TO INTERMITTENT CONNECTIONS ON FLASH CHIPS U102 AND U105. THE ROOT CAUSE OF THE INTERMITTENT CONNECTIONS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE STRESS ON THE MONITOR C/A BOARD. A ROOT CAUSE INVESTIGATION IS UNDERWAY. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE MONITOR WAS NOT ISSUED TO A PT AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE (PSR) CONTRACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT MONITOR SN (B)(4) WAS RESETTING. THE MONITOR WAS NOT ISSUED TO A PT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109043 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA