BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23097153 · Received September 19, 2025

    Report

    Report Number
    1218950-2025-000540
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 29, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 REPORTING INSTITUTION PHONE#: (B)(6). THE EVENT TOOK PLACE ON AUGUST 21, 2025, AT 23:22 HOURS ON BED 45_12T. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. THERE WERE NO ERRORS CODES AND THE DEVICE WAS FOUND TO FUNCTION AS EXPECTED. THE LOGS AND A PHOTO OF THE AUDIT LOG WERE RETRIEVED BY THE FSE. A REVIEW OF THE LOGS BY THE FSE FOUND ASYSTOLE ALARMING AT 23:23:59. THE FSE EVALUATED THE PIC IX AND DISCOVERED THAT THE MINIMUM VOLUME WAS SET TO 1. THIS IS A VERY QUIET SETTING. THE ALLEGATION INDICATES THAT THE THREE NURSES WHO WERE AT THE CONTROL CENTER AT THE TIME OF THE INCIDENT DID NOT HEAR THE ALARM. THE ALARM VOLUME WAS INCREASED FROM 1 TO 5 BY THE FSE. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CHANGED THE SOFTWARE VERSION TO 4.2 AND CHANGED THE MANUFACTURER REGISTRATION CFN/FEI. PLEASE REFER TO MFR# 9610816-2025-000891 FOR THE COMPLETE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NURSES DID NOT HEAR THE ASYSTOLE ALARM AND THE NURSES THOUGHT THE ALARM DID NOT OCCUR OR WAS SENT TOO LATE TO THE CENTRAL STATION. THE PATIENT FAINTED AND THEN RANG THE NURSE CALL, AFTER WHICH A 17.7 SECOND EPISODE OF ASYSTOLE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723237 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX C.03.10 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening