BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUKUDA DENSHI

    MDR report key: 3515411 · Received November 18, 2013

    Report

    Report Number
    9611031-2013-00001
    Event Type
    Death
    Date Received
    November 18, 2013
    Date of Event
    October 16, 2013
    Report Date
    November 18, 2013
    Manufacturer
    FUKUDA DENSHI CO., LTD.
    Product Code
    MHX
    PMA / PMN Number
    K033711
    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 THOROUGH EXPLANATION OF DEVICE OPERATION AND THE IMPORTANCE OF ROUTINELY CHECKING THE DEVICE POWER SOURCE AND MONITORING OF THE CENTRAL STATION.

    Description of Event or Problem · 1

    EVENT: THIS EVENT OCCURRED IN A (B)(6) HOSPITAL ON (B)(6) 2013 AND REPORTED TO US BY THE HOSPITAL ON (B)(4) 2013. A MEDICAL STAFF NOTICED THE PT ECG WAVEFORM ON THE CENTRAL MONITOR STATION, (B)(4), SCREEN TO BE A SQUARE WAVEFORM INDICATING THE PT BEING MONITORED ON A TELEMETRY TRANSMITTER MONITOR, LX-5230, WAS OFF-LINE, OUT OF RANGE, OR NOT CONNECTED. THE MEDICAL STAFF PERSON RUSHED INTO PT ROOM AND FOUND THE PT HAD EXPIRED. UPON EXAMINATION OF THE TELEMETRY TRANSMITTER MONITOR, IT WAS DETERMINED THAT THE BATTERY POWER OF TELEMETER LX-5230 WAS EXHAUSTED. THIS EVENT WAS DUE TO USER ERROR AND NOT DUE TO ANY MALFUNCTION OF DEVICE, WHICH WAS ALSO ACKNOWLEDGED BY THE FACILITY. THE TELEMETRY TRANSMITTER MONITOR INVOLVED IN THIS EVENT IS THE FUKUDA DENSHI MODEL LX-5230 WHICH IS SOLD IN THE (B)(4) MARKET BUT WHICH IS SIMILAR TO THE FUKUDA DENSHI TELEMETRY TRANSMITTER MONITOR LX-5630 WHICH IS DISTRIBUTED AND SOLD IN THE US MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596121 FUKUDA DENSHI TELEMETRY TRANSMITTER MONITOR MHX FUKUDA DENSHI CO., LTD. LX-5320

    Patients

    Seq Age Sex Outcome Treatment
    1 Death