BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 14013342 · Received April 5, 2022

    Report

    Report Number
    1051786-2022-00025
    Event Type
    Death
    Date Received
    April 5, 2022
    Date of Event
    March 11, 2022
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MWI
    UDI-DI
    00884838084902
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE STAFF HAD TO REBOOT THE FC2010 TO GET THE MONITORING TO RETURN. DURING THIS TIMEFRAME, THEY DID HAVE AN ALTERNATE ECG BEING WATCHED ON THE DEFIB MACHINE. THEY PERFORMED SUBSEQUENT SHOCKS WITH NO FURTHER ISSUES. ONCE THE CASE, WAS DONE, THE BIOMED CAME AND SWAPPED THE FC2010 DEVICE WITH A SPARE DEVICE. THE CUSTOMER DID CONFIRM THAT DUE TO THE PATIENTS PRIOR CONDITION THAT THE FC2010 DEVICE DID NOT HAVE ANY AFFECT ON THE OUTCOME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO ADDRESS THE REPORTED PROBLEM. THE DEVICE EVALUATION WAS PERFORMED BY THE FSE ON THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. ACCORDING TO THE FSE, THE SPARE DEVICE IS CURRENTLY IN SERVICE. THE FSE BROUGHT THE DEVICE IN QUESTION BACK INTO THE CATH LAB AND THOROUGHLY TESTED IT. THE FSE REPORTEDLY REIMAGED THE DEVICE BUT NOTED THAT THE DEVICE WAS FUNCTIONING AS INTENDED BEFORE AND AFTER THE REIMAGE. THE DEVICE PASSED ALL FUNCTIONAL TESTING AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. CUSTOMER WILL USE THIS DEVICE AS THE NEW SPARE. THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER AND WAS REPLACED BY BIOMED WITH AN ON HAND SPARE. ONSITE FIELD SERVICE WAS UNABLE TO CONFIRM THE REPORTED PROBLEM DURING HIS EVALUATION. BECAUSE OF THIS, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF CAUSE UNKNOWN. THE DEVICE IN QUESTION WAS REIMAGED AND FUNCTIONALITY CONFIRMED. A REPLACEMENT DEVICE IS NOW IN USE AT THE CUSTOMER'S FACILITY. SUBSEQUENT TO THE RECEIPT OF THIS COMPLAINT, AN ISSUE IMPACT ASSESSMENT (IIA-2975-2022-511) WAS SUBMITTED FOR THE ISSUE REPORTED. ANY ADDITIONAL INVESTIGATION OR ACTION TAKEN WILL BE DOCUMENTED IN THE RESPECTIVE RECORD.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAD A VERY SICK PATIENT COME INTO THE LAB THAT THEY HAD TO DO CPR ON. STAFF USED THE DEFIBRILLATOR AND WHEN THEY DID THE FIRST SHOCK, THE FC2010 DEVICE WENT BLANK ON THE BOOM AND CONTROL ROOM (HOST) SHOWED AN OFF MESSAGE. THE PATIENT DIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAD A VERY SICK PATIENT COME INTO THE LAB THAT THEY HAD TO PERFORM CPR (CARDIOPULMONARY RESUSCITATION) ON. STAFF USED A DEFIBRILLATOR AND WHEN THEY DID THE FIRST SHOCK, THE FC2010 DEVICE WENT BLANK ON THE BOOM MONITOR AND THE CONTROL ROOM (HOST PC) DISPLAYED AN OFF MESSAGE. THE PCI (PERCUTANEOUS CORONARY INTERVENTION) WAS UNSUCCESSFUL AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94822 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM XPER FLEX CARDIO PHYSIOMONITORING SYSTEM MWI INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS 453564634201 00884838084902

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death