BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 12869353 · Received November 24, 2021

    Report

    Report Number
    1051786-2021-10072
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    November 1, 2021
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MWI
    UDI-DI
    00884838084902
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ACCORDING TO THE FSE, THE CUSTOMER WAS USING A SPARE UNIT UPON ARRIVAL SO HE COULD NOT CONFIRM THE CUSTOMER'S REPORTED PROBLEM. THE FSE REIMAGED THE DEVICE IN QUESTION AND TESTED THE UNIT. THE DEVICE PASSED ALL FUNCTIONAL TESTING AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. A SEARCH IN SALESFORCE FOUND NO FURTHER RELATED CALLS. THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER. HOWEVER, ONSITE FIELD SERVICE WAS UNABLE TO CONFIRM THE REPORTED PROBLEM. BECAUSE OF THIS, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF CAUSE UNKNOWN. THE ATTENDING FSE REIMAGED THE DEVICE AND CONFIRMED FUNCTIONALITY. THE DEVICE REMAINS 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AFTER SHOCKING A PATIENT, THE ECG FLATLINES DURING BOVIE OR DEFIB USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HAVING A STEMI (ST-ELEVATION MYOCARDIAL INFARCTION) CASE IN WHICH THEY HAD TO SHOCK THE PATIENT WITH A DEFIBRILLATOR (AT APPROX.4:04 AND 4:07AM). ACCORDING TO THE CUSTOMER, RIGHT AFTER SHOCKING THE PATIENT, THEY HAD A FLATLINE ECG ON THE BOOM MONITOR (CUSTOMER IS UNSURE IF THIS WAS THE SAME IN THE CONTROL ROOM). THE ECG REPORTEDLY NEVER RECOVERED, AND THE SYSTEM HAD TO BE REBOOTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AFTER SHOCKING A PATIENT, THE ECG FLATLINES DURING BOVIE OR DEFIB USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767432 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 Unknown Required Intervention