BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO VISION CENTRAL STATION

    MDR report key: 584874 · Received March 21, 2005

    Report

    Report Number
    1051786-2005-00002
    Event Type
    Death
    Date Received
    March 21, 2005
    Date of Event
    March 5, 2005
    Report Date
    March 21, 2005
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS FOUND AT 19:20 UNRESPONSIVE WITH THE TRANSMITTER DISCONNECTED AND ON THE FLOOR. ATTEMPTS TO REVIVE WERE UNSUCCESSFUL. A REVIEW OF THE PRODUCT'S FULL DISCLOSURE SHOWS TRANSMISSION WAS LOST AT 14:50 (OVER 5 HOURS) BEFORE THE PT WAS FOUND IN THE ABOVE STATED UNRESPONSIVE STATE. THE CUSTOMER REPORTED THAT THEY DID NOT REMEMBER HEARING THE ALARMS AND COULD NOT VERIFY WHETHER THE ALARMS WERE OFF/OR THE SOUND WAS TURNED DOWN AT THE TIME OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death