BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE PATIENT MONITOR MX750

    MDR report key: 23865543 · Received December 22, 2025

    Report

    Report Number
    9610816-2025-001275
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 22, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838083332
    PMA / PMN Number
    K210906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHILIPS REMOTE CLINICAL SUPPORT (RCS) PERSONNEL FOLLOWED UP WITH THE BIOMED WHO CONFIRMED THAT THE NICU MONITORS ARE CONFIGURED TO VISUAL AND AUDIBLE LATCHING ALARM FOR "RED ONLY". THE RCS ADVISED THE BIOMED TO REVIEW THE CLINICAL AUDIT TRAIL EVENTS TO CONFIRM THIS ALARM BEHAVIOR. THE RCS FOLLOWED UP WITH THE BIOMED AGAIN, THEY ADVISED THAT THEY SPOKE WITH THEIR CLINICAL CONSULTANT WHO INFORMED THEM THAT THE MONITOR DOES NOT LATCH TECHNICAL ALARMS. THE RCS EXPLAINED THIS IS CORRECT; HOWEVER, THE MONITOR DOES LATCH THE PHYSIOLOGICAL ALARMS EX: *** RED ALARM AND ** YELLOW ALARM IF CONFIGURED. THE RCS FOLLOWED UP WITH THE BIOMED AND ADVISED THE NEXT STEP WOULD BE TO DISPATCH THE ONSITE TECHNICAL ENGINEER TO INVESTIGATE THE MONITORS' ALARM LATCHING BEHAVIORS. THE BIOMED STATED THE SHOP SUPERVISOR SAID TO CLOSE THE CASE. THE RCS INFORMED CLINICAL CONSULTANT THAT THE CUSTOMER HAS CREATED ANOTHER CASE REGARDING THEIR NICU MONITORS RED ALARM LATCHING BEHAVIOR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE NICU MONITORS' RED ALARMS RESET WITHOUT USER INTERVENTION. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746202 INTELLIVUE PATIENT MONITOR MX750 INTELLIVUE PATIENT MONITOR MX750 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX750 00884838083332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown