BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASCOPE DS-3300 TELEMETRY SYSTEM

    MDR report key: 174101 · Received June 23, 1998

    Report

    Report Number
    3031158-1998-00001
    Event Type
    Injury
    Date Received
    June 23, 1998
    Date of Event
    June 14, 1998
    Report Date
    June 15, 1998
    Manufacturer
    FUKUDA DENSHI CO., LTD; QA DEPT.
    Product Code
    DRG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON JUNE 15, 1998 THE HOSP REPORTED A TELEMETRY MALFUNCTION. "BLEED-OVER" FROM ANOTHER TELEMETRY TRANSMITTER CAUSED A "NORMAL" WAVEFORM TO APPEAR ON THE CHANNEL OF A DIFFERENT MONITORED PT. A "NORMAL" ECG WAS DISPLAYED EVEN THOUGH THE PT WAS DEAD. THE SYS DID NOT ALARM. THE HOSP CONSIDERS THIS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNASCOPE DS-3300 TELEMETRY SYSTEM TELEMETRY RECEIVER DRG FUKUDA DENSHI CO., LTD; QA DEPT. LW-3100 *
    2 DYNASCOPE DS-3300 TELEMETRY SYSTEM TELEMETRY TRANSMITTER DRG FUKUDA DENSHI CO., LTD; QA DEPT. ST-17 *
    3 DYNASCOPE DS-3300 TELEMETRY SYSTEM TELEMETRY CENTRAL STATION (DISPLAY) DRT FUKUDA DENSHI CO., LTD; QA DEPT. DS-3300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *