BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21592247 · Received March 13, 2025

    Report

    Report Number
    9610816-2025-000197
    Event Type
    Death
    Date Received
    March 13, 2025
    Date of Event
    November 27, 2024
    Report Date
    March 13, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838121782
    PMA / PMN Number
    K211900
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS A SUPPLEMENTAL TO 1218950-2024-000886 DUE TO INCORRECT REGISTRATION NUMBER USED. LOGS WERE ABLE TO BE OBTAINED AND WERE REVIEWED BY THE PHILIPS REMOTE SERVICE ENGINEER (RSE) AND A PHILIPS PRODUCT SUPPORT ENGINEER (PSE). AN ALARM-CHAIN CONFIGURATION REQUIRES ASSIGNMENT OF A ¿LEVEL¿, ¿DEVICE¿, AND ¿USER¿ TO BE SUCCESSFUL. REVIEW OF THE AVAILABLE LOGS REVEALED THAT THE SETTINGS WERE COMPLETE AND ACCURATE FOR USERS ¿SSK A¿ AND ¿SSK B¿ WHO RECEIVED THE MOBILE ALARM VIA THE SYSTEM AS EXPECTED. FOR USER(S) WHO DID NOT RECEIVE THE MOBILE ALARMS, THE CONFIGURATION WAS FOUND TO BE INCOMPLETE. THE AVAILABLE LOGS START AT (B)(6) 2024 AND SHOW THE SAME DEVICE CONFIGURATION UP UNTIL THE EVENT DATE, WHICH DID NOT INCLUDE MOBILE ALARMS CONFIGURED FOR ALL USERS. THUS, IT IS NOT POSSIBLE TO DETERMINE WHEN THIS CONFIGURATION WAS CHOSEN BY THE CUSTOMER. A POSSIBLE DELAY IN THE HEALTHCARE PROFESSIONAL¿S AWARENESS OR TREATMENT OF THE PATIENT¿S CONDITION, WHICH WOULD NOT BE CAPTURED IN EVENT LOGS. AS THE ALARMS OCCURRED CLOSE TOGETHER, IT IS UNCLEAR IF TREATMENT WAS PROVIDED AFTER THE FIRST INSTANCE OF THE ALARM AND BEFORE THE SECOND ALARM OCCURRED. BOX E: REPORTING ADDRESS STATE: (B)(6). REPORTING INSTITUTION PHONE #: +\(B)(6). REPORTER PHONE #: +(B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT ALL USERS THAT WERE INTENDED TO GET ALARM NOTIFICATIONS DID NOT GET THESE NOTIFICATIONS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. DURING THIS INCIDENT, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991232 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866389 00884838121782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death