BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 22039307 · Received May 16, 2025

    Report

    Report Number
    9610816-2025-000422
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 22, 2025
    Report Date
    August 8, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838020733
    PMA / PMN Number
    K150310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE ENGINEER PULLED LOGS AND WENT OVER THEM WITH THE CUSTOMER. AT TIME OF REPORT, ADDITIONAL INFORMATION IS BEING REQUESTED. 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. E1; REPORTER INSTITUTION PHONE NUMBER:(B)(6). E1: REPORTER PHONE NUMBER:(B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO SECTION D ¿ FDA PROCODE AND MODEL . PHILIPS FIELD SERVICE ENGINEER (FSE) STATED THAT THE CLINICAL ENGINEER AT THE HOSPITAL WAS CHECKING THE LOGS AND IT REVEALED THAT VARIOUS ALARMS WERE ACTIVE. LOGS WERE OBTAINED, REVIEWED, AND WENT OVER WITH THE CUSTOMER. THE TARGET BED IS NICU19 AND THE INCIDENT OCCURRED AROUND 3:37 ON (B)(6) 2025. IT WAS ALSO NOTED THAT THE CLINICAL AUDIT TRAIL SHOWS OTHER ACTIVE RED ALARMS OCCURRED DURING THIS TIME, AND THESE ALARMS WERE ACKNOWLEDGED AT THE BEDSIDE MONITOR. PRODUCT SUPPORT ENGINEER( PSE) EVALUATED THE DATA AVAILABLE FOR NICU19 ON APRIL 21 AROUND 3:37 A.M. WHICH CONFIRMED THE ASSESSMENT OF THE FSE THAT A - DESAT ALARM 40<85 AT 3:37 A.M WHICH INDICATED A DROP IN SATURATION BELOW 80. HOWEVER, THE DESAT ALARM ENDED AT 3:37 A.M. DUE TO SILENCING OF THE ALARMS. THE ALARMS WERE VERY SHORT, ALTHOUGH THERE WERE MANY OF THEM. AT 3:37 THE ALARMS WERE SILENCED AT THE BEDSIDE MONITOR. PLETH WAVEFORM IS NOT DISPLAYING PROPERLY, WHICH IS CONSIDERED THE UNDERLYING ISSUE. (B)(6) 2025 03:37, NICU19 BRADY/P41 < 50 ENDED MXNICU19 RED ALARM. (B)(6) 2025 03:37, NICU19 SPO2 NO PULSE OCCURRED MXNICU19 INOP. (B)(6) 2025 03:37, NICU19 ALARM SILENCE MXNICU19 ALARM SILENCE. (B)(6) 2025 03:37, NICU19 SPO2 NO PULSE ENDED MXNICU19 INOP. BASED ON THIS INFORMATION, THERE DOES NOT APPEAR TO BE ANY DEVICE MALFUNCTION AS ALARMS WERE GENERATED AND SILENCED AT THE BEDSIDE MONITOR; HOWEVER, IT IS RECOMMENDED THAT THE CUSTOMER CHECK THE SPO2 SENSOR, SPO2 ADAPTER CABLE FOR INTEGRITY AND THE PATIENT ENVIRONMENT BE CHECKED FOR SOURCES OF ELECTRICAL INTERFERENCE. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INFORMATION FROM THE LOGS WERE PROVIDED TO THE CUSTOMER. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT SPO2 DROPPED BELOW 80 BUT NO ALARM SOUNDED. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143617 INTELLIVUE MX800 PATIENT MONITOR INTELLIVUE MX800 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR 00884838020733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown