BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE PATIENT MONITOR MX750

    MDR report key: 23719925 · Received December 4, 2025

    Report

    Report Number
    9610816-2025-001166
    Event Type
    Death
    Date Received
    December 4, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 4, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838083332
    PMA / PMN Number
    K210906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING INSTITUTION NAME: (B)(6). A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER AND DISPATCHED A FIELD SERVICE ENGINEER (FSE) ONSITE TO DOWNLOAD THE LOGS FOR FURTHER EVALUATION. SUMMARY OF TECHNICAL COMPLAINT INVESTIGATION: THE LOGS WERE REVIEWED BY AN INTERNAL PHILIPS CLINICAL SPECIALIST AND PROVIDED THE FOLLOWING ANALYSIS: THE ALARM SETTING CONFIGURATION FOR THE ASSOCIATED BEDSIDE MONITOR IS SET TO SPLIT LATCHED; AUDIBLE NON-LATCH: OFF, AND VISUAL LATCHING: RED AND YELLOW. THIS MEANS WHEN THE ALARM CONDITION IS NO LONGER ACTIVE, THE ALARM SOUND STOPS BUT THE VISUAL ALARM BANNER/TEXT REMAINS VISIBLE UNTIL ACKNOWLEDGED. IT WAS ALSO NOTED THAT THESE HAVE BEEN THE CONFIGURATION STANDARDS FOR THE FACILITY FOR THE LAST 10+ YEARS. WHEN GIVEN THE OPPORTUNITY TO UPDATE THE CONFIGURATION, THE HOSPITAL SETTINGS WERE REQUESTED TO REMAIN UNCHANGED. THE PHILIPS ACCOUNT EXECUTIVE DISCUSSED THESE SETTINGS WITH THE THP CLINICAL DIRECTOR AND THERE WAS AN ACKNOWLEDGEMENT THAT NO CHANGES NEEDED TO BE MADE AT THIS TIME. THERE IS AN ABP MEAN ALARM FOR 53<60 GENERATED AT 10:40. (B)(6) 2025 10:40 1 ABPM 53<60 / ALARM ANNUNCIATED / 10:40:30 / (B)(4). (B)(6) 2025 10:44 2 ABP CHANGE SCALE / ALARM ENDED / 10:44:08 / (B)(4). (B)(6) 2025 10:48 2 ABP CHANGE SCALE / ALARM ANNUNCIATED / 10:48:11 / (B)(4). (B)(6) 2025 10:49 2 ABP CHANGE SCALE / ALARM ENDED / 10:49:33 / (B)(4). (B)(6) 2025 10:51 2 ABP CHANGE SCALE / ALARM ANNUNCIATED / 10:51:19 / (B)(4). (B)(6) 2025 10:51 2 ABP CHANGE SCALE / ALARM ENDED / 10:51:20 / (B)(4). (B)(6) 2025 10:51 2 ABP CHANGE SCALE / ALARM ANNUNCIATED / 10:51:24 / (B)(4). (B)(6) 2025 10:51 2 ABP CHANGE SCALE / ALARM ENDED / 10:51:25 / (B)(4). (B)(6) 2025 10:59 1 ABPM LOW / ALARM ENDED / 10:59:27 / (B)(4). IT PLAYED UNTIL 10:59:27 WHEN THE ALARM WAS ACKNOWLEDGED AT THE MONITOR. PIC IX CLINICAL AUDIT LOG: ON (B)(6) 2025 10:59:27 THP M-SITE RM 4 ACKNOWLEDGE 2FICU-MON-4 ACKNOWLEDGE. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS A CONFIGURATION ISSUE. THE REPORTED PROBLEM WAS CONFIRMED. THERE WAS NO MALFUNCTION ASSOCIATED WITH THE UNIT. 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

    IT WAS REPORTED THERE WERE NO AUDIBLE ALARMS FOR SPO2 OR BLOOD PRESSURE. IT WAS INDICATED THE FAMILY NOTICED THE PATIENT WAS IN DISTRESS AND THE PATIENT CODED. THE ICU EDUCATOR CONFIRMED THE SPO2 ALARMS WERE TURNED OFF BUT THE MONITOR AND CENTRAL STATION DID NOT GENERATE AN AUDIBLE ALARM FOR A LOW INVASIVE BLOOD PRESSURE; HOWEVER, THE STAFF INDICATED THE VISUAL ALARMS WERE FLASHING ON THE MONITOR SCREEN. THE PATIENT REQUIRED INTUBATION, BUT NO OTHER PATIENT OUTCOME DETAILS WERE PROVIDED AT THE TIME OF THE COMPLAINT. THE FIELD SAFETY ENGINEER WENT ONSITE AND PULLED ALL DEVICE LOGS. THE PATIENT PASSED AWAY AFTER CARE WAS WITHDRAWN BY FAMILY. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447943 INTELLIVUE PATIENT MONITOR MX750 INTELLIVUE MX750 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX750 00884838083332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death