BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUKUDA DENSHI

    MDR report key: 3784233 · Received April 24, 2014

    Report

    Report Number
    9611031-2014-00001
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 21, 2014
    Manufacturer
    FUKUDA DENSHI CO., LTD.
    Product Code
    MHX
    PMA / PMN Number
    K103134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED SOLELY AS A RESULT OF USER ERROR AND NOT DUE TO ANY MALFUNCTION OF THE DEVICE. AND AS PER FUKUDA DENSHI CO. LTD. QA SYSTEM SOP, IS WAS DETERMINED TO BE A REPORTABLE EVENT AND THEREFORE AN FDA FORM 3500A WAS ORDERED TO BE FILED. IN ADDITION, AS A RESULT OF THIS EVENT, THE HOSPITAL STAFF WERE PROVIDED WITH ADDITIONAL INSTRUCTION AND A THOROUGH EXPLANATION OF DEVICE OPERATION AND THE IMPORTANCE OF ALARM FUNCTIONS AND SETTINGS OF THE CENTRAL STATION.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT A JAPANESE HOSPITAL ON (B)(6) 2014 AND REPORTED TO US BY THE FACILITY ON (B)(6) 2014. THE DEVICE WAS THE FUKUDA DENSHI TELEMETRY TRANSMITTER DEVICE MODEL LX-7230N WHICH WAS BEING WIRELESSLY MONITORED BY A CENTRAL STATION MONITOR, THE FUKUDA DENSHI MODEL DS-7680. THESE ARE SIMILAR DEVICES TO THE ONES BEING DISTRIBUTED IN THE U.S. THE CENTRAL STATION SHOWED A SQUARE ECG WAVEFORM ON THE MONITORED PT INDICATING THE DEVICE WAS PUT OF SIGNAL RANGE WITH THE CENTRAL STATION. WHEN THE PT WAS FOUND, THE PT APPEARED TO HAVE LOST CONSCIOUSNESS. THE CENTRAL STATION HAS AN ALARM FUNCTION THAT ALERTS THE CLINICIAN WHEN A SIGNAL IS LOST DUE TO OUT OF RANGE BUT THIS FEATURE WAS TURNED OFF BY THE USER. OTHER TRANSMITTERS TRANSMITTING FROM PTS TO THE CENTRAL STATION AT THE SAME TIME IN THE HOSPITAL WERE OPERATING NORMALLY. THE DEVICE AND ITS ACCESSORIES WERE INVESTIGATED AND FOUND TO HAVE NO MALFUNCTION IN ANY OF THEM. THIS ADVERSE EVENT WAS NOT DUE TO ANY MALFUNCTION OF THE DEVICE BUT RATHER DUE TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250311 FUKUDA DENSHI ECG, RESP. & SPO2 TRANSMITTER LX-7230 MHX FUKUDA DENSHI CO., LTD. LX-7320N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other