BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1550326 · Received December 2, 2009

    Report

    Report Number
    1051786-2009-00018
    Event Type
    Injury
    Date Received
    December 2, 2009
    Report Date
    May 20, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K040915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE IT WAS REPORTED THAT A PT CODED, WE WILL CONSIDER THE REPORT TO HAVE BEEN A SERIOUS INJURY. THE INVIVO DEVICE WAS NOT IN USE BEFORE, DURING OR AFTER THE CODE WAS CALLED AND THERE WAS NO ADVERSE OUTCOME TO THE PT. THERE WAS NO ALLEGATION AND THERE IS NO INDICATION THAT THE INVIVO DEVICE WAS A FACTOR IN THE CODE OR IN THE PT'S OUTCOME. THE DECISION TO NOT MONITOR A CONSCIOUS SEDATION, PT WAS A CLINICAL DECISION OUTSIDE THE USE OF THE MONITOR.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THEY HAD A CONSCIENCE SEDATION CASE AND THE PT CODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION MAGNITUDE MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3150M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention