BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERIES IV

    MDR report key: 6090467 · Received November 9, 2016

    Report

    Report Number
    1051786-2016-00015
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K033030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE TECHNICAL SUPPORT ENGINEER (TSE), THAT THE CUSTOMER WAS ABLE TO RESOLVE THE REPORTED ISSUE BY REPLACING THE HOST DEVICE WITH AN ON-HAND SPARE. THE CUSTOMER CONFIRMED THE REPLACEMENT SYSTEM IS FUNCTIONING AS INTENDED. THE TSE MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND TO COMMUNICATE PHILIPS¿ DESIRE TO EVALUATE THE DEVICE INVOLVED IN THE INCIDENT. HOWEVER, THE CUSTOMER DID NOT RESPOND TO THESE REQUESTS. THEREFORE, THE REPORTED PROBLEM WAS NOT CONFIRMED BY PHILIPS. CONSERVATIVELY, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF INSUFFICIENT INFORMATION / CAUSE UNKNOWN BECAUSE THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER AND THE AVAILABLE INFORMATION DOES NOT SUPPORT HOW THIS COULD BE A USER MISUNDERSTANDING.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY CALLED ON (B)(6) 2016 AND REPORTED THAT THEY HAD A PATIENT ON THE TABLE AND COULD NOT SEE THE PATIENT'S VITALS ON THE SLAVE AND BOOM SCREENS. THE CUSTOMER STATED THAT THEY RESOLVED THE ISSUE BY REPLACING THE HOST / CONTROL ROOM STATION WITH A UNIT FROM ANOTHER FACILITY. LATER, DURING A CALL ON (B)(6) 2016, IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT EXPIRED. AT THE TIME OF THE CUSTOMER'S INITIAL CALL ON (B)(6) 2016, THERE WAS NO REPORT OF A PATIENT DEATH. THE DEVICE WAS IN CLINICAL USE FOR PATIENT MONITORING AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. IT IS UNKNOWN IF MEDICAL INTERVENTION OCCURRED AND TO WHAT EXTENT. THERE WAS NO REPORT OF AN ALTERNATE MONITORING SOURCE OR REDUNDANT MONITORING CAPABILITIES BEING USED IN THIS CASE, AS DESCRIBED IN THE DEVICE'S INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739906 SERIES IV CARDIOVASCULAR MONITOR MWI INVIVO CORPORATION 452230033301

    Patients

    Seq Age Sex Outcome Treatment
    1 Death