BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23241715 · Received October 8, 2025

    Report

    Report Number
    1218950-2025-000585
    Event Type
    Death
    Date Received
    October 8, 2025
    Date of Event
    September 1, 2025
    Report Date
    October 21, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K183387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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.

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER WHO MENTIONED THAT CLINICAL LEADERSHIP REQUESTED THE PATIENT'S DISCHARGED STORED HISTORY AND ALARM EVENTS BECAUSE THEY ARE INVESTIGATING THE ROOT CAUSE OF THIS PATIENT'S DEATH THAT HAPPENED ON (B)(6) 2025. THE DEVICE LOGS WERE COLLECTED AND SENT TO AN INTERNAL PHILIPS PRODUCT SUPPORT ENGINEER (PSE) WHO SENT IT TO THE CLINICAL PRODUCT SPECIALIST (CPS) FOR FURTHER ANALYSIS. SUMMARY OF TECHNICAL COMPLAINT INVESTIGATION: PER CPS AN ASYSTOLE ALARM WAS GENERATED AT 19:41:30 AND ENDED AT 20:28:49. THE ALARM REMINDED AND WAS ACKNOWLEDGED FROM THE PIC IX. ASYSTOLE WAS GENERATED AGAIN AT 20:28:51, THEN THE ECG LEADS CAME OFF THE PATIENT AT 20:30:44. THERE WERE SPO2T ALARMS, INOPS AND DESAT ALARMS GENERATED AROUND THIS TIME AS WELL. PHILIPS CANNOT DETERMINE THE ROOT CAUSE OF THE PATIENT DEATH, THE MONITOR ALARMED FOR A RED ARRHYTHMIA ALARM, WAS ACKNOWLEDGED AND THE ALARM PERSISTED AS THE PATIENT WAS STILL IN THAT RHYTHM PER THE AUDIT LOG. (B)(6) 2025 19:41:33 (B)(6) 3S351 PAUSE GENERATED AT 19:41:28. PIC IX: WDIX49 (B)(6) 2025 19:41:33 (B)(6) 3S351 PAUSE GENERATED AT 19:41:28. PIC IX: WDIX44 (B)(6) 2025 19:41:35 (B)(6) 3S351 ASYSTOLE GENERATED AT 19:41:30. PIC IX: WDIX49 (B)(6) 2025 19:41:35 (B)(6) 3S351 ASYSTOLE GENERATED AT 19:41:30. PIC IX: WDIX44 (B)(6)2025 19:41:35 (B)(6) 3S351 PAUSE ENDED. PIC IX: WDIX44 (B)(6)2025 19:41:35 (B)(6) 3S351 PAUSE ENDED. PIC IX: WDIX49 (B)(6)2025 19:42:26 (B)(6) 3S351 REMIND MX16 (B)(6)2025 19:45:32 (B)(6) 3S351 REMIND MX16 (B)(6)2025 19:48:30 (B)(6) 3S351 ACKNOWLEDGE WDIX44 (B)(6)2025 19:51:32 (B)(6) 3S351 REMIND MX16 (B)(6)2025 19:54:38 (B)(6) 3S351 REMIND MX16 9/1/2025 19:57:44 (B)(6) 3S351 REMIND MX16 (B)(6)2025 19:57:49 (B)(6) 3S351 ACKNOWLEDGE WDIX44 (B)(6)2025 20:00:50 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:03:56 (B)(6) 3S351 REMIND MX16 9/1/2025 20:07:03 (B)(6) 3S351 REMIND MX16 9/1/2025 20:10:09 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:13:14 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:16:20 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:19:27 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:22:33 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:22:36 (B)(6) 3S351 ACKNOWLEDGE WDIX44 (B)(6)2025 20:25:38 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:28:44 (B)(6) 3S351 REMIND MX16 (B)(6)2025 20:28:49 (B)(6) 3S351 ASYSTOLE ENDED. PIC IX: WDIX49 (B)(6)2025 20:28:49 (B)(6) 3S351 ASYSTOLE ENDED. PIC IX: WDIX44 (B)(6)2025 20:28:55 (B)(6) 3S351 PAUSE GENERATED AT 20:28:49. PIC IX: WDIX49 (B)(6)2025 20:28:55 (B)(6) 3S351 PAUSE GENERATED AT 20:28:49. PIC IX: WDIX44 (B)(6)2025 20:28:57 (B)(6) 3S351 ASYSTOLE GENERATED AT 20:28:51. PIC IX: WDIX44 (B)(6)2025 20:28:57 (B)(6) 3S351 ASYSTOLE GENERATED AT 20:28:51. PIC IX: WDIX49 (B)(6)2025 20:28:57 (B)(6) 3S351 PAUSE ENDED. PIC IX: WDIX44 (B)(6)2025 20:28:57 (B)(6) 3S351 PAUSE ENDED. PIC IX: WDIX49 (B)(6)2025 20:30:21 (B)(6) 3S351 SPO2T 79 <90 GENERATED AT 20:30:15. PIC IX: WDIX44 (B)(6)2025 20:30:21 (B)(6) 3S351 SPO2T 79 <90 GENERATED AT 20:30:15. PIC IX: WDIX49 (B)(6)2025 20:30:32 (B)(6) 3S351 DESAT 78 < 85 GENERATED AT 20:30:27. PIC IX: WDIX49 (B)(6)2025 20:30:32 (B)(6) 3S351 DESAT 78 < 85 GENERATED AT 20:30:27. PIC IX: WDIX44 (B)(6)2025 20:30:32 (B)(6) 3S351 SPO2T 78 <90 ENDED. PIC IX: WDIX44 (B)(6)2025 20:30:32 (B)(6) 3S351 SPO2T 78 <90 ENDED. PIC IX: WDIX49 (B)(6)2025 20:30:50 (B)(6) 3S351 !! ECG LEADS OFF GENERATED AT 20:30:44. PIC IX: WDIX49 (B)(6)2025 20:30:50 (B)(6) 3S351 !! ECG LEADS OFF GENERATED AT 20:30:44. PIC IX: WDIX44 (B)(6)2025 20:31:30 (B)(6) 3S351 ANNOTATION STORED: (B)(6)2025 19:41:30 ASYSTOLE RE-LABELED TO ***ASYSTOLE*** NOTI. RN - HU/MT PIC IX: WDIX44 (B)(6)2025 20:36:12 (B)(6) 3S351 !! ECG LEADS OFF ENDED. PIC IX: WDIX49 (B)(6)2025 20:36:12 (B)(6) 3S351 !! ECG LEADS OFF ENDED. PIC IX: WDIX44 (B)(6)2025 20:39:20 (B)(6) 3S351 ANNOTATION STORED: 9/1/2025 20:20:53 SAVED STRIP RE-LABELED TO ***ASYSTOLE*** NOTI. RN, IN ROOM W/PT - HU/MT PIC IX: WDIX44 (B)(6)2025 20:39:32 (B)(6) 3S351 ACKNOWLEDGE WDIX44 BASED ON THE INFORMATION AVAILABLE AND THE LOGS PROVIDED, THE MONITOR ALARMED FOR A RED ARRHYTHMIA ALARM WAS ACKNOWLEDGED. THE SYSTEM WAS CONFIRMED TO BE WORKING ACCORDING TO SPECIFICATIONS. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED FOLLOWING THE PATIENT'S DEATH, THE CUSTOMER REQUESTED ASSISTANCE OBTAINING THE PATIENT'S STORED DATA AS A PART OF THEIR INVESTIGATION INTO THE ROOT CAUSE OF THE PATIENT'S DEATH. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION; HOWEVER, GOOD FAITH EFFORTS ARE BEING PERFORMED TO OBTAIN FURTHER INFORMATION. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513027 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX C.03.08

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death