BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM

    MDR report key: 5474014 · Received March 2, 2016

    Report

    Report Number
    1051786-2016-00004
    Event Type
    Death
    Date Received
    March 2, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 1, 2016
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE DEVICE AT THE CUSTOMER'S REQUEST. PER FSE, THE MONITOR WAS OPERATING AS EXPECTED DURING HIS VISIT. THE FSE REPORTED THAT THE CUSTOMER CLAIMED THAT THEY HAVE SEEN SOME PROLONGED SIGNAL LOSS IN THE PAST (NOT ASSOCIATED WITH THIS PARTICULAR CASE). THE FSE STATED THAT HE DID NOT NOTICE ANY SIGNAL LOSS WHILE ONSITE, BUT THOUGHT BASED ON THE CUSTOMER'S STATEMENTS THAT THE CUSTOMER SITE COULD USE A PASSIVE ANTENNA. THE PASSIVE ANTENNA SYSTEM IS NOT SOMETHING NORMALLY INSTALLED AT CUSTOMER SITES UPON PURCHASE OF A MONITORING SYSTEM, BUT CAN BE INSTALLED IF THE CUSTOMER EXPERIENCES COMMUNICATION ISSUES. NOT EVERY CUSTOMER SITE REQUIRES A PASSIVE ANTENNA SYSTEM TO BE INSTALLED. NO PARTS WERE REPLACED BY THE FSE AND THE DEVICE REMAINS AT THE CUSTOMER SITE. THE FSE NOTED THAT HE WAS PLANNING TO DISCUSS A PASSIVE ANTENNA INSTALLATION WITH THE SALES REP. THE CUSTOMER REQUESTED TESTING AND VERIFICATION OF THE DEVICE FOLLOWING WHAT WAS INITIALLY DESCRIBED AS A PATIENT CODE THAT OCCURRED THE PREVIOUS NIGHT DURING AN MRI SCAN. LATER, IT WAS LEARNED BY THE FSE THAT THE CODE OCCURRED IMMEDIATELY AFTER THE PATIENT LEFT THE MRI ROOM AND THE PATIENT SUBSEQUENTLY PASSED AWAY. THE CUSTOMER DID NOT ALLEGE THAT THERE WAS DELAYED TREATMENT OF THE PATIENT AND THE DEVICE REPORTEDLY ALARMED AS EXPECTED WHEN THE PATIENT CODED. THE FSE FOUND THE DEVICE TO BE OPERATING AS EXPECTED DURING HIS SITE VISIT.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED TESTING AND VERIFICATION OF THE DEVICE FOLLOWING A PATIENT CODE. ACCORDING TO THE CUSTOMER, A PATIENT CODED THE PREVIOUS NIGHT DURING AN MRI SCAN. THE CUSTOMER CLAIMED THAT THEY WERE NOT STATING THAT THE DEVICE CAUSED ANY ISSUE, BUT THAT IT IS HOSPITAL PROTOCOL TO HAVE ALL EQUIPMENT CONNECTED TO THE PATIENT VERIFIED AFTER ANY INCIDENT. THE PATIENT WAS REPORTEDLY BEING MONITORED WITH ECG AND SPO2 AND WAS VENTILATED. THE CUSTOMER CLAIMED THAT THE MRI STAFF HAD REPORTED INTERFERENCE OCCURRING DURING A DIFFERENT TYPE OF SCAN IN THE PAST, BUT THAT THERE WAS NO REPORT OF ANY SUCH ISSUE DURING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130649 INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention