BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUKUDA DENSHI

    MDR report key: 281961 · Received June 7, 2000

    Report

    Report Number
    9611031-2000-00002
    Event Type
    Malfunction
    Date Received
    June 7, 2000
    Report Date
    May 31, 2000
    Manufacturer
    FUKUDA DENSHI CO., LTD.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THEY HAVE MONITORED PATIENTS WITH EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION THAT THE DS-5800 TELEMETRY SYSTEM DID NOT RECOGNIZE AND DID NOT ALARM ON. ON THE EVENING OF APRIL 13, 2000 FUKUDA DENSHI RECEIVED A 10 PAGE FAX WITH EXAMPLES OF EVENTS THAT WERE RECOGNIZED AND EVENTS THAT WERE NOT RECOGNIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI TELEMETRY CENTRAL STATION DSI FUKUDA DENSHI CO., LTD. DS-5800NX *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other