BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE X3

    MDR report key: 18354598 · Received December 19, 2023

    Report

    Report Number
    9610816-2023-00672
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    October 10, 2023
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838082588
    PMA / PMN Number
    K171801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION ERROR, AND THE AUDIO WAS NOT WORKING. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE BIOMEDICAL ENGINEER, AND THE DIRECTOR OF ICU INITIALLY STATED THAT THERE WAS A "MX800 SPEAKER MALFUNCTION ERROR ACROSS 5 ICU'S WITH 16 BEDS EACH." THE RSE SENT X3, MX450, AND MX800 SERVICE GUIDE TO THE BIOMEDICAL ENGINEER VIA SDT. THE RSE RECOMMENDED THAT THE BIOMEDICAL ENGINEER TAKE TIME TO TRY TO WITNESS THE EXACT ERROR MESSAGE ON BEDSIDE MONITORING EQUIPMENT. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO FULLY INVESTIGATE THE ISSUE, AS THERE WAS INITIALLY INDICATION OF A WIDESPREAD ISSUE. THE FSE CONFIRMED WITH THE BIOMEDICAL ENGINEER REGARDING THE INITIAL HIGH FREQUENCY SPEAKER MALFUNCTION, AND THE BIOMEDICAL ENGINEER ADVISED THAT THERE WERE 14 TOTAL X3'S THAT THE CUSTOMER REPAIRED. THE FSE ADVISED THAT THE CUSTOMER REPLACED THE SPEAKER. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE SPEAKER. THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS OPERATIONAL AFTER REPLACING THE SPEAKER. ADDITIONAL CASES WERE REPORTED. PLEASE REFER TO MFR #S: 9610816-2023-00515; 9610816-2023-00673; 9610816-2023-00672; 9610816-2023-00674; 9610816-2023-00675; 9610816-2023-00676; 9610816-2023-00677; 9610816-2024-00021; 9610816-2024-00025; 9610816-2024-00022; 9610816-2024-00023; 9610816-2024-00026; 9610816-2024-00024; 9610816-2024-00027.

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE X3 INDICATING THAT THERE WAS A SPEAKER MALFUNCTION ERROR, AND THE AUDIO WAS NOT WORKING. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE BIOMEDICAL ENGINEER, AND THE DIRECTOR OF ICU INITIALLY STATED THAT THERE WAS A "MX800 SPEAKER MALFUNCTION ERROR ACROSS 5 ICU'S WITH 16 BEDS EACH." THE RSE SENT X3, MX450, AND MX800 SERVICE GUIDE TO THE BIOMEDICAL ENGINEER VIA SDT. THE RSE RECOMMENDED THAT THE BIOMEDICAL ENGINEER TAKE TIME TO TRY TO WITNESS THE EXACT ERROR MESSAGE ON BEDSIDE MONITORING EQUIPMENT. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO FULLY INVESTIGATE THE ISSUE, AS THERE WAS INITIALLY INDICATION OF A WIDESPREAD ISSUE. THE FSE CONFIRMED WITH THE BIOMEDICAL ENGINEER REGARDING THE INITIAL HIGH FREQUENCY SPEAKER MALFUNCTION, AND THE BIOMEDICAL ENGINEER ADVISED THAT IT IS NOT AN ISSUE. THERE IS NO LARGE BATCH OF X3S OR PARTICULAR INSTALL ORDER OF X3S THAT CAN BE TRACED BACK HAVING ISSUES WITH SPEAKERS CONSISTENTLY. THE BIOMEDICAL ENGINEER CONFIRMED THAT THE CASE CAN BE CLOSED. THE FSE WAS ADVISED THAT THE CUSTOMER REPLACED THE SPEAKER. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE SPEAKER. THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS OPERATIONAL AFTER REPLACING THE SPEAKER. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION ERROR, AND THE AUDIO WAS NOT WORKING. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472912 INTELLIVUE X3 INTELLIVUE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867030 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown