BEUDAMED
    FDA Adverse Event Death Summary report: N

    #1 ESCORT VISION CENTRAL STATION

    MDR report key: 562971 · Received December 29, 2004

    Report

    Report Number
    562971
    Event Type
    Death
    Date Received
    December 29, 2004
    Date of Event
    November 1, 2004
    Report Date
    December 23, 2004
    Manufacturer
    MEDICAL DATA ELECTRONICS (INVIVO MDE)
    Product Code
    DRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO ED AT 0823 IN 2004 WITH COMPLAINTS OF CHEST PAIN. CARDIAC MONITORING INITIATED UPON ADMISSION. DIAGNOSTIC WORK-UP INDICATIVE OF GI BLEED AND NON-Q-WAVE MI. PT FOUND NON RESPONSIVE @ 1337. CODE CALLED PT EXPIRED @ 1351. INVESTIGATION REVEALED: ARRHYTHMIA ANALYSIS OFF AT CENTRAL MONITOR, BED SIDE AUDIBLE ALARM TONE WAS OFF. ADMIT/DISCHARGE/TRANSFER FUNCTION NOT UTILIZED. NEITHER THE ARRHYTHMIA ANALYSIS OR BEDSIDE AUDIBLE RATE ALARMS RETURN TO DEFAULT SETTINGS. BIO-MED STAFF TESTED THE CENTRAL MONITOR AND BEDSIDE MONITOR. THE FUNCTIONALITY AND CONFIGURATION OF BOTH UNITS WAS FOUND TO BE APPROPRIATE. MONITORING SYSTEM DOES NOT REQUIRE THE USER TO UTILIZE THE ADMIT/DISCHARGE/TRANSFER FUNCTION.

    Description of Event or Problem · 1

    THE DEVICE IS CURRENTLY IN USE AT THE FACILITY. AN IN-SERVICE WAS COMPLETED ON THE DEVICE IN 2004 BY TECHNICAL SERVICE REP. IT WAS CONFIRMED THAT THE ARRHYTHMIA ANALYSIS AND ALARMS WERE TURNED OFF AT THE BEDSIDE. SINCE THE INCIDENT OCCURRED, THE HOSPITAL HAS CHANGED THE UNIT TO "PASSWORD PROTECT" THE ARRHYTHMIA ANALYSIS, SO IT CANNOT BE TURNED OFF. ALSO, AMPLIFIERS WERE ADDED TO THE DEVICE'S SPEAKERS SO THE ALARMS ARE VERY LOUD IN THE VERY BUSY EMERGENCY DEPT. THE TECHNICAL SERVICE REP ALSO PROVIDED THE ASSISTANT MD LAMINATED QUICK REFERENCE TRAINING GUIDES FOR A REFRESHER TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 #1 ESCORT VISION CENTRAL STATION VITAL SIGNS/ARRHYTHMIA MONITORING DRG MEDICAL DATA ELECTRONICS (INVIVO MDE) 20500-16 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death