BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1675649 · Received April 27, 2010

    Report

    Report Number
    1051786-2010-00013
    Event Type
    Injury
    Date Received
    April 27, 2010
    Date of Event
    March 20, 2010
    Report Date
    March 31, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CONSIDERING THAT THERE WAS A NEED FOR EMERGENT CARE BECAUSE THE PATIENT WAS REPORTED AS HAVING CODED. THEREFORE, THIS IS CONSIDERED AS A SERIOUS INJURY FOR A PATIENT WHO WAS BEING MONITORED USING AN INVIVO MONITOR. THE AVAILABLE INFORMATION SUPPORTS THAT THERE WAS NO DEVICE MALFUNCTION OR FAILURE TO PERFORM AS INTENDED. THE DEVICE MANUFACTURER IS CURRENTLY INVESTIGATING THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT AFTER THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT A PATIENT CODED IN THE MRI MAGNET ROOM AND THAT THEY WERE HAVING PROBLEMS IN GETTING ECG DURING SOME OF THE SCAN SEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION PRECESS (3160 SERIES) MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention