BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 25171518 · Received May 14, 2026

    Report

    Report Number
    9610816-2026-100937
    Event Type
    Death
    Date Received
    May 14, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 14, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K211900
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. E1: REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS REPORTED UNDER INCORRECT REGISTRATION NUMBER, PLEASE REFER TO 1218950-2026-100384 FOR FURTHER INFORMATION REGARDING THIS COMPLAINT.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE DEVICE DID NOT ALARM AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566142 PATIENT INFORMATION CENTER IX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

    Patients

    Seq Age Sex Outcome Treatment
    1