BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISION CENTRAL STATION

    MDR report key: 298786 · Received September 29, 2000

    Report

    Report Number
    2022870-2000-00003
    Event Type
    Death
    Date Received
    September 29, 2000
    Date of Event
    August 17, 2000
    Report Date
    September 24, 2000
    Manufacturer
    MEDICAL DATA ELECTRONICS
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT WENT INTO CARDIAC ARREST, THE CENTRAL MONITORING SYSTEM RESPONDED WITH A LOW LIMIT HEART RATE VIOLATION AND SOUNDED A LEVEL 3 ALARM PRIORITY AS PROGRAMMED BY THE USERS. THE USERS DID NOT IMMEDIATELY DETECT THE ALARM CONDITION. THEY HAVE DETERMINED THEY WANT HEART RATE ALARM LEVEL TO BE CHANGED TO A LEVEL 1 ALARM PRIORITY TO ENSURE THE NURSING STAFF WILL IMMEDIATELY RESPOND TO AN ALARM EVENT IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION CENTRAL STATION VISION SURVEILLENCE MONITORING SYSTEM DRT MEDICAL DATA ELECTRONICS 20500-16 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other