BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO/MDE

    MDR report key: 1309505 · Received February 6, 2009

    Report

    Report Number
    1051786-2009-00001
    Event Type
    Death
    Date Received
    February 6, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 13, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER VISITED THE CUSTOMER SITE AND PERFORMED EXTENSIVE FUNCTIONAL TESTING ON THE ENTIRE SYSTEM. WHEN PRESENTED WITH LIFE THREATENING ALARMS, THE ENTIRE SYSTEM RESPONDED APPROPRIATELY AND PRODUCED BOTH VISUAL AND AUDIBLE ALARMS ON ALL CONDITIONS, AS EXPECTED. THE SYSTEM WAS FOUND TO BE FUNCTIONING AS DESIGNED AND INTENDED. DURING THE SITE VISIT, IT WAS FOUND THAT ONLY FOUR (4) CHANNELS OF ARRHYTHMIA WERE CONFIGURED FOR EACH OF TWO CENTRAL STATION SYSTEMS AT THE CUSTOMER SITE (THIS WAS THE CONFIGURATION OF THE SYSTEM AS PURCHASED BY THE USER FACILITY). IT WAS FOUND THAT DURING THE EVENT IN QUESTION, ALL FOUR CHANNELS OF ARRHYTHMIA WERE ASSIGNED TO OTHER PATIENTS AND ARRHYTHMIA WAS NOT MONITORED FOR THE SUBJECT PATIENT DURING THE EVENT. IT WAS ALSO FOUND IN A REVIEW OF THE EVENT HISTORY THAT A LOW HEART RATE ALARM WAS PRODUCED BY THE SYSTEM, BUT THIS ALARM WAS NOT ACKNOWLEDGED BY THE USER. WE WILL CONSIDER THAT THE FAILURE OF THE CLINICAL STAFF TO ACTIVATE ARRHYTHMIA MONITORING FOR THIS PATIENT AND THE FAILURE OF THE STAFF TO RESPOND TO THE LOW HEART RATE ALARM WERE BOTH FACTORS IN THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    USER FACILITY STATED THAT A PATIENT EXPIRED AND THAT NO ALARMS SOUNDED FROM THE PATIENT MONITORING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO/MDE ESCORT LINK CENTRAL STATION DRT INVIVO CORPORATION 20500-16

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death