BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 16700356 · Received April 7, 2023

    Report

    Report Number
    3003768277-2023-02190
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 9, 2023
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MWI
    UDI-DI
    00884838083820
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED UNDER CFN/FEI 3003768277 AND SHOULD BE UNDER 1051786. A COMPLETE REPORT WAS SUBMITTED UNDER MFR REPORT NUMBER 1051786-2023-00006.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN IN THE MIDDLE OF PATIENT CODING, WOULD LIKE SOMEONE TO LOOK AT PATIENT LOGS. THE CUSTOMER INDICATED PATIENT HARM; HOWEVER, NO DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, PATIENT STATUS AND EVENT DETAILS ARE UNKNOWN. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ASSISTED THE BIOMED WITH THE LOGS AND THERE WAS NO RELEVANT DEVICE DATA FOUND DURING THE TIME FRAME OF THE ALLEGED FAILURE. IN ADDITION, THE RSE IDENTIFIED THE DEVICE WAS NOT BEING SHUTDOWN IN ORDER TO PREVENT FAILURES DURING CASES AND THAT THERE HAS NOT BEEN ANY PREVENTATIVE MAINTENANCE (PM) PERFORMED ON DEVICES. THE CUSTOMER WAS PROVIDED WITH DOCUMENTATION ON THESE PROCEDURES SO THEY CAN PERFORM PM WORK, AND THE STAFF WAS INSTRUCTED THAT THESE DEVICES NEED TO BE SHUTDOWN AND RESTARTED DAILY BEFORE CASES ARE PERFORMED. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EVENT. THE EVENT DETAILS WERE REVIEWED BY A PHILIPS SR. PRODUCT SUPPORT ENGINEER WHO STATED THE LIKELY CAUSE OF THE EVENT IS THE FLEX CARDIO WAS OVER ENERGIZED PAST THE BOUNDS OF OUR SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785129 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM XPER FLEX CARDIO PHYSIOMONITORING SYSTEM MWI INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS 453564667151 00884838083820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention