BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 16543238 · Received March 15, 2023

    Report

    Report Number
    1218950-2023-00125
    Event Type
    Death
    Date Received
    March 15, 2023
    Date of Event
    February 28, 2023
    Report Date
    December 18, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. REPORTER INSTITUTION PHONE NUMBER: N/A. REPORTER PHONE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS RECORD WAS UPDATED AS PART OF A RETROSPECTIVE REVIEW. D1 BRAND NAME, D2A: COMMON DEVICE NAME, D4 MODEL #, CATALOG #, SERIAL # AND UDI WERE UPDATED FROM THE PIC IX HARDWARE (866424) TO THE PIC IX SOFTWARE (866389). G1 CONTACT OFFICE WAS UPDATED. G4 510K WAS CORRECTED FROM K102495 TO K153702. H4 MANUFACTURE DATE WAS CORRECTED FROM 05/14/2018 TO 03/24/2020. H6 CONCLUSION CODE GRID WAS UPDATED. H11 ADDED ADDITIONAL DETAILS FROM THE INVESTIGATION SUMMARY. ADDED RELATED REPORT NUMBER 1218950-2023-00121 FOR THE MX40 PATIENT MONITOR. AUDIT LOG REVIEW REVEALED AN APPROPRIATE ALARM OCCURRED AT THE CENTRAL STATION. BASED ON THIS INFORMATION AND THE AUDIBLE ALARM TESTING PERFORMED BY THE HOSPITAL BIOMED, IT DOES NOT APPEAR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL DETAILS WERE REQUESTED; HOWEVER, THE HOSPITAL WOULD NOT RELEASE ADDITIONAL INFORMATION. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT ARRESTED AND THERE WAS NO AUDIBLE ALARM AT THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT. A PATIENTS DEATH WAS REPORTED. FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE FSE OBTAINED THE REQUESTED PIIC LOGS AND MX40 PWM LOGS. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE LOGS. BASED ON THE REVIEW OF THE PIC IX AND MX40 PWM LOG AND ALARM REVIEW DATA, THE PSE DETERMINED THAT THE MX40 PERFORMED AS SPECIFIED AND RECOGNIZED AND ALARMED FOR CHANGES IN THE PATIENT¿S CONDITION. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT NO AUDIBLE ALARM AT THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT. A PATIENTS DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913964 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death