BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEVENT WIRELESS CARDIAC EVENT MONITOR

    MDR report key: 9134509 · Received September 30, 2019

    Report

    Report Number
    2133409-2019-00012
    Event Type
    Death
    Date Received
    September 30, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 26, 2019
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146EP010
    PMA / PMN Number
    K171410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BRAEMAR MANUFACTURING, LLC HAS COMPLETED A PRELIMINARY EVALUATION OF THE RETURNED DEVICE. THE DEVICE WAS RECEIVED AT BRAEMAR MANUFACTURING, LLC EAGAN, MN ON 09/06/2019. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE AFFECTED DEVICE INDICATED THAT THIS WEVENT ER920W 3G CDMA WAS ORIGINALLY SHIPPED TO THE DISTRIBUTOR ON 02/14/2017. THERE IS NO HISTORY OF FACTORY SERVICE AT BRAEMAR MANUFACTURING, LLC (EAGAN, MN). PRODUCTION LINE AND FINAL TEST PROCEDURES WERE PERFORMED, WITH NO FAILURES IDENTIFIED. ENGINEERING INVESTIGATION OF THE DEVICE IDENTIFIED NO DEVICE MALFUNCTION OR FAILURES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT'S DEATH. THIS REPORT IS BEING SUBMITTED DUE TO THE INITIAL REPORTER'S NOTIFICATION OF PATIENT DEATH WHILE WEARING THE DEVICE. ADDITIONAL EVALUATION ACTIVITIES ARE BEING PERFORMED BY BRAEMAR MANUFACTURING, LLC. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON 08/28/2019, M.D., DIRECTOR REGIONAL SALES ((B)(6)) RECEIVED A PHONE CALL FROM (B)(6) NOTIFYING OF PATIENT EXPIRY. THE PATIENT WAS IN A NURSING FACILITY (LOCATED IN (B)(6)) AND HAD BEEN WEARING THE WEVENT MONITOR S/N (B)(4) FOR ABOUT THREE (3) DAYS. THE PATIENT WAS FOUND DECEASED OVERNIGHT (FOUND ON (B)(6) 2019) WHILE STILL WEARING THE DEVICE. THE MEDICAL EXAMINER REMOVED THE DEVICE AND THE NURSING STAFF OBTAINED IT FROM THE MORGUE. THE DEVICE WAS RETURNED TO BRAEMAR MANUFACTURING, LLC ON 09/06/2017 UNDER RMA R011745. THE PATIENT CAUSE OF DEATH, IF DETERMINED, IS UNKNOWN TO BRAEMAR MANUFACTURING, LLC AND (B)(6). THIS REPORT IS BEING SUBMITTED DUE TO NOTIFICATION OF PATIENT DEATH WHILE WEARING THE WEVENT MONITOR. THE BECOME AWARE DATE FOR BRAEMAR MANUFACTURING, LLC IS 09/04/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928245 WEVENT WIRELESS CARDIAC EVENT MONITOR WEVENT WIRELESS CARDIAC EVENT MONITOR DSI BRAEMAR MANUFACTURING, LLC 900-0612-01 B146EP010

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death