BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORP. PRECESS MRI PATIENT MONITORING SYSTEM

    MDR report key: 3807864 · Received May 6, 2014

    Report

    Report Number
    1051786-2014-00005
    Event Type
    Death
    Date Received
    May 6, 2014
    Report Date
    April 7, 2014
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FACILITY SENT THE DEVICE MANUFACTURER'S SALES REPRESENTATIVE AN EMAIL ASKING FOR TRAINING ON THE DEVICE FOR ICU NURSES. IT WAS LATER DISCLOSED THAT A PATIENT HAD EXPIRED WHILE BEING MONITORED WITH THE DEVICE. IT WAS REPORTED THAT THE PATIENT CALLED PEA (PULSELESS ELECTRICAL ACTIVITY) OR ELECTROMECHANICAL DISSOCIATION. THIS REFERS TO A CARDIAC ARREST SITUATION IN WHICH A HEART RHYTHM IS OBSERVED ON THE ELECTROCARDIOGRAM THAT SHOULD BE PROVIDING A PULSE, BUT IS NOT. UNDER NORMAL CIRCUMSTANCES, ELECTRICAL ACTIVATION OF MUSCLE CELLS PRECEDES MECHANICAL CONTRACTION OF THE HEART. IN PEA, THERE IS ELECTRICAL ACTIVITY, BUT THE HEART EITHER DOES NOT CONTRACT OR THERE ARE OTHER REASONS WHY THIS RESULTS IN AN INSUFFICIENT CARDIAC OUTPUT TO GENERATE A PULSE AND SUPPLY BLOOD TO THE ORGANS. THE DEVICE MANUFACTURER HAS ATTEMPTED TO CONTACT THE USER FACILITY MULTIPLE TIMES FOR ADDITIONAL INFORMATION ABOUT THE INCIDENT, BUT THE USER FACILITY HAS REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION BECAUSE THEY CLAIM THAT THE DEVICE DID NOT FAIL. AS A RESULT, THE DEVICE MANUFACTURER DOES NOT KNOW THE DATE THE PATIENT EXPIRED OR ANY ADDITIONAL INFORMATION ABOUT THE ACTUAL PATIENT OR WHAT OCCURRED DURING THE CASE. THE DEVICE MANUFACTURER IS CONTINUING TO INVESTIGATE THIS REPORT AND WILL FILE A FINAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE USER FACILITY SENT THE DEVICE MANUFACTURER'S SALES REPRESENTATIVE AN EMAIL ASKING FOR TRAINING ON THE DEVICE FOR ICU NURSES. IT WAS LATER DISCLOSED THAT A PATIENT HAD EXPIRED WHILE BEING MONITORED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271221 INVIVO CORP. PRECESS MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death