BEUDAMED
    FDA Adverse Event Death Summary report: N

    DYNASCOPE DS-3300 TELEMETRY SYSTEM

    MDR report key: 199381 · Received November 24, 1998

    Report

    Report Number
    6000090-1998-00003
    Event Type
    Death
    Date Received
    November 24, 1998
    Date of Event
    June 14, 1998
    Report Date
    July 22, 1998
    Manufacturer
    FUKUDA DENSHI CO., LTD.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE U.S. DISTRIBUTOR, FUKUDA DENSHI AMERICA CORP., REPORTED THAT A PT DIED WHILE CONNECTED TO A FUKUDA DENSHI TELEMETRY SYSTEM. THE REPORT SAID THAT A SIGNAL FROM ANOTHER TRANSMITTER OVERPOWERED THE SIGNAL FROM THE PT'S TRANSMITTER AND WAS REC'D AND DISPLAYED AT THE CENTRAL STATION. THE SIGNAL DETECTED AND DISPLAYED WAS INTERPRETED AS "NORMAL". NO ALARMS WERE SOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNASCOPE DS-3300 TELEMETRY SYSTEM CENTRAL STATION DSI FUKUDA DENSHI CO., LTD. DS-3300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death NO OTHER PRODUCTS/DEVICES HAVE BEEN REPORTED.