BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUKUDA DENSHI

    MDR report key: 1908069 · Received November 10, 2010

    Report

    Report Number
    9611031-2010-00001
    Event Type
    Death
    Date Received
    November 10, 2010
    Date of Event
    September 24, 2010
    Report Date
    November 10, 2010
    Manufacturer
    FUKUDA DENSHI USA, INC.
    Product Code
    DSI
    PMA / PMN Number
    K980728
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED MDR REPORT FROM UF ON 10/12/2010. MADE CONTACT WITH FACILITY ON 10/14/2010. DETERMINED THAT THE DEVICE WAS INDICATING LOW BATTERY SYMBOL ON CENTRAL DISPLAY AND BATTERY CAP WAS BROKEN AT TIME OF REPORTED INCIDENT. BATTERY CAP WAS TAPED ON THE DEVICE TO MAINTAIN OPERATION. PRIOR TO REPORT, SPARE BATTERY CAPS WERE SECURED WITH BIOMED. AFTER INCIDENT, CUSTOMER REPLACED THE BROKEN BATTERY CAP AND INSTALLED A NEW BATTERY AND DETERMINED DEVICE OPERATION WAS NORMAL. THE DEVICE HAS NEVER BEEN RETURNED PREVIOUSLY FOR ANY REPAIR. CUSTOMER HAS SINCE PROVIDED SPARE BATTERY CAPS TO THE NURSE STATION TO ENSURE THEY ARE AVAILABLE AS REQUIRED. CUSTOMER BELIEVES THEY HAVE SUFFICIENT STOCK OF BATTERY CAPS. CURRENTLY, THE DEVICE LX-5160 (B)(4) IS SECURED AT THE RISK MANAGER OFFICE PENDING REVIEW FROM CORPORATE HQ. ADVISED CUSTOMER THAT IF THEY FEEL THAT THE DEVICE IS NOT WORKING PROPERLY OR HAS ANY ISSUE THAT THEY REMOVE IT FROM USE AND RETURN THE DEVICE OR EVAL REPAIR. ADVISED THAT OUR (800) NUMBER IS AVAILABLE 24/7/365 IS THEY HAVE ANY QUESTIONS, CONCERNS OR ISSUES THAT THEY MAY NEED ASSISTANCE WITH. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(4): TELEMETRY BOX.

    Description of Event or Problem · 1

    AS PER UF REPORT: PT WAS ON TELEMETRY, BUT TELEMETRY WASN'T SHOWING RHYTHM. TOP OF TELEMETRY UNIT FOUND TAPED TO TELEMETRY CHANNEL. SCREW FOR BATTERY COVER HAD WORN AND HAD BEEN TAPED IN PLACE. TAPE HAD COME LOOSE AND BATTERIES DID NOT CONNECT PROPERLY. PT FOUND UNRESPONSIVE, NO RESPIRATION, WEAK PULSE. CODE BLUE CALLED, FAMILY REQUESTED CPR STOPPED. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI TELEMETRY TRANSMITTER DSI FUKUDA DENSHI USA, INC. LX-5160

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death