BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO VISION CENTRAL STATION

    MDR report key: 599801 · Received May 5, 2005

    Report

    Report Number
    1051786-2005-00003
    Event Type
    Death
    Date Received
    May 5, 2005
    Date of Event
    March 25, 2005
    Report Date
    May 4, 2005
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED INQUIRING ABOUT SYSTEM FUNCTIONALITY - SPECIFICALLY IF THERE WAS A WAY TO DETERMINE IF ARRHYTHMIA ALARMS WERE TURNED OFF OR ON DURING SPECIFIC EVENTS. THE BIOMEDICAL ENGINEER STATED THAT THE NURSING STAFF INFORMED PT THE VISION SYSTEM HAD NOT ALARMED DURING THE EVENT. THE HARD DRIVE WAS RETURNED TO INVIVO FOR ANALYSIS AND IT WAS DETERMINED THAT THE ARRHYTHMIA ALARMS WERE TURNED OFF AND WERE NOT TURNED BACK ON UNTIL AFTER THE PERIOD OF INTEREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO VISION CENTRAL STATION CARDIAC MONITOR DRT INVIVO CORPORATION 20500-16 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death