BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM

    MDR report key: 6409417 · Received March 16, 2017

    Report

    Report Number
    1051786-2017-00006
    Event Type
    Death
    Date Received
    March 16, 2017
    Date of Event
    February 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT HAD EXPIRED AND THAT THE CUSTOMER WAS REQUESTING THAT THE DEVICE BE CHECKED OUT BY AN FSE. THE CUSTOMER CLAIMED THAT THE PATIENT HAD PREEXISTING CONDITIONS AND THAT THE PATIENT'S CONDITION WAS ¿NOT GOOD¿ AND THE PATIENT DECLINED QUICKLY. THE DEVICE'S NIBP WAS REPORTEDLY WORKING INTERMITTENTLY AND ETCO2 REPORTEDLY STOPPED WORKING COMPLETELY DURING THE CASE. THE CUSTOMER CLAIMED THAT A BACKUP (TRANSPORT) MONITOR WAS PUT INTO USE WHEN ISSUES WITH THE PHILIPS DEVICE WERE ENCOUNTERED. FSE EVALUATION OF THE PHILIPS DEVICE FOUND THAT THE WPU/CART WAS NOT COMMUNICATING WITH THE DCU/DISPLAY AND SPO2/ECG MODULES, WHICH IS DIFFERENT FROM THE CUSTOMER REPORTED ISSUE. THIS TYPE OF COMMUNICATION ISSUE WOULD RENDER THE DEVICE INOPERABLE. TO RESOLVE THE COMMUNICATION ISSUE, THE WPU/CART¿S RADIO WAS REPLACED. THE FSE ALSO FOUND THAT THE DEVICE¿S BATTERIES WERE 7 YEARS OLD AND NEEDED TO BE REPLACED. REPLACEMENT OF THE DEVICE¿S BATTERIES SHOULD BE DONE BY THE CUSTOMER YEARLY AS PART OF MAINTENANCE OF THE DEVICE. THE CUSTOMER REPORTED NIBP AND ETCO2 PROBLEMS WERE NOT DUPLICATED DURING FSE EVALUATION. THE CUSTOMER DID NOT RESPOND TO PHILIPS¿ MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION ABOUT THE REPORTED PATIENT EVENT. THEREFORE, NO CONCLUSION CAN BE MADE AS TO WHETHER THE REPORTED ISSUES ENCOUNTERED WITH THE PHILIPS DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PHILIPS ACCOUNT MANAGER CONTACTED PHILIPS MARKETING ON BEHALF OF THE CUSTOMER AND REPORTED THAT A PATIENT HAD EXPIRED AT THIS CUSTOMER SITE AND THAT THE CUSTOMER WAS REQUESTING THAT THE DEVICE BE CHECKED OUT BY AN FSE. THE CUSTOMER CLAIMED THAT THE PATIENT HAD PREEXISTING CONDITIONS AND THAT THE PATIENT'S CONDITION WAS ¿NOT GOOD¿ AND THE PATIENT DECLINED QUICKLY. THE DEVICE'S NIBP WAS REPORTEDLY WORKING INTERMITTENTLY AND ETCO2 REPORTEDLY STOPPED WORKING COMPLETELY DURING THE CASE. THE CUSTOMER CLAIMED THAT A BACKUP (TRANSPORT) MONITOR WAS PUT INTO USE WHEN THESE ISSUES WERE DISCOVERED. THE DEVICE WAS BEING USED FOR PATIENT MONITORING WHEN THE INCIDENT OCCURRED AND THE PATIENT REPORTEDLY EXPIRED.

    Description of Event or Problem · 1

    PHILIPS ACCOUNT MANAGER CONTACTED PHILIPS MARKETING ON BEHALF OF THE CUSTOMER AND REPORTED THAT A PATIENT HAD EXPIRED. THE CUSTOMER WAS REQUESTING THAT THE DEVICE BE CHECKED OUT BY AN FSE. THE CUSTOMER CLAIMED THAT THE PATIENT HAD PREEXISTING CONDITIONS AND THAT THE PATIENT'S CONDITION WAS NOT GOOD AND THE PATIENT DECLINED QUICKLY. THE DEVICE'S NIBP WAS REPORTEDLY WORKING INTERMITTENTLY AND THE ETCO2 STOPPED WORKING COMPLETELY DURING THE CASE. THE CUSTOMER CLAIMED THAT A BACKUP (TRANSPORT) MONITOR WAS PUT INTO USE. THE DEVICE WAS BEING USED FOR PATIENT MONITORING WHEN THE INCIDENT OCCURRED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193156 INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1 Death