BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1647359 · Received March 29, 2010

    Report

    Report Number
    1051786-2010-00011
    Event Type
    Injury
    Date Received
    March 29, 2010
    Date of Event
    February 12, 2010
    Report Date
    February 23, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K040915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER STATED THAT THEY DID NOT KNOW IF THE DEVICE MALFUNCTIONED BUT THEY WANTED THE DEVICE EVALUATED, DUE TO THE CODE BLUE. THE USER PERFORMED NUMEROUS TESTS ON THE DEVICE, INCLUDING ECG, SPO2, NIBP AND BATTERY TESTING, AND NO PROBLEMS WERE DETECTED. THE USER ALSO TESTED THE SPO2 ACCESSORIES AND FOUND NO ISSUES. FINALLY, THE USER PERFORMED PREVENTIVE MAINTENANCE ON THE DEVICE WITH NO PROBLEMS NOTED. THE DEVICE WAS RETURNED TO THE DEVICE MANUFACTURER FOR BENCH EVALUATION. ALL MANUFACTURER SUGGESTED TESTS AND FUNCTIONAL CHECKS PASSED WITH NO ISSUES. THE DEVICE WAS ALLOWED TO RUN OVERNIGHT TO OBSERVE FOR MALFUNCTIONS AND NONE WERE DETECTED. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED OR FAILED TO ALERT THE CLINICIANS TO A CHANGE IN PATIENT STATUS. AS A RESULT, CLINICIANS WERE ABLE TO APPLY AVAILABLE THERAPY TO THE PATIENT WITHOUT DELAY. ALSO, THE CHANGE IN THE PATIENT'S STATUS WAS NOT UNEXPECTED, GIVEN THE PATIENT'S PRE-EXISTING CONDITION (MULTIPLE TRAUMAS). NO ADDITIONAL INVESTIGATION OR ACTIONS BY THE DEVICE MANUFACTURER ARE WARRANTED.

    Description of Event or Problem · 1

    THE USER STATED THAT THERE WAS A REPORTED PROBLEM WITH THE PATIENT'S SPO2 AND THAT THERE WAS A "LACK OF OXYGEN ISSUE". DURING THE SCANNING OF A MULTIPLE TRAUMA PATIENT, IT WAS REPORTED THAT THE PATIENT'S SPO2 INITIALLY WAS 96% AND THEN DROPPED TO 84% AND THEN TO 74%. THE PATIENT WAS CYANOTIC WHEN REMOVED FROM THE MRI MACHINE. A CODE BLUE WAS CALLED AND THE PATIENT WAS TRANSFERRED BACK TO ICU.

    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 46 YR Required Intervention