BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23271005 · Received October 10, 2025

    Report

    Report Number
    1218950-2025-000590
    Event Type
    Death
    Date Received
    October 10, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 20, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 TECHNICAL CONSULTANT (TC) WENT TO THE CUSTOMER SITE. THE TC CONFIRMED THAT THE PATIENT DID NOT DIE AND WAS STILL IN THE SAME HOSPITAL ROOM. THE TC WAS ABLE TO OBTAIN THE ALARM LOGS FOR THE BED (LABEL #2223). THE CUSTOMER WANTED TO CHECK THE LOGS FROM 10:00AM (B)(6) 2025 TO 07:00AM ON (B)(6) 2025. THE CUSTOMER BIOMED STATED THAT THE ALARMS WERE TURNED OFF ON (B)(6) 2025 AT ABOUT 11:10AM THEN THE EVENT OCCURRED ON (B)(6) 2025 AT ABOUT 2:00AM. A REVIEW OF THE LOG NOTED MULTIPLE ARTERIAL BLOOD PRESSURE (ABP) RED ALARMS, JUST PRIOR TO 10:00AM ON (B)(6) 2025, WHICH HAD BEEN SILENCED AT THE BEDSIDE MONITOR. AT 10:01 THERE WAS A PAUSE ALL ALARMS, FOLLOWED BY A RESUME ALL ALARMS AT 10:03AM: (B)(6) 2025 10:03 2223 RESUME ALL ALARMS M2223. (B)(6) 2025 10:01 2223 PAUSE ALL ALARMS M2223. ABP ALARMS CONTINUED AFTER THE ALARMS WERE RESUMED, AND WERE SILENCED AT THE BEDSIDE MONITOR AND ALSO THE SURVEILLANCE (PIIC IX) THROUGH 10:46AM: (B)(6) 2025, 10:46 2223 ***ABPM 30 <50 ENDED. PIIC IX: ICUSURV3 (B)(6) 2025, 10:46 2223 SILENCE M2223 (B)(6) 2025, 10:45 , 2233 ***ABPM 39 <50 GENERATED AT 10:45:32. PIIC IX: ICUSURV3; (B)(6) 2025, 10:31 , 2233 ***ABPS 78 <80 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025, 10:31 , 2233 SILENCE ICUSURV3; (B)(6) 2025, 10:30 , 2233 **ABPS 196 >160 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025, 10:30 , 2233 ***ABPS 78 <80 GENERATED AT 10:30:43. PIIC IX: ICUSURV3; (B)(6) 2025, 10:13 , 2233 **ABPS 196 >160 GENERATED AT 10:13:38. PIIC IX: ICUSURV3; (B)(6) 2025, 10:13 , 2233 ***ABPS 196 >175 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025, 10:13 , 2233 SILENCE M, 2233 (B)(6) 2025, 10:12 , 2233 **ABPS 178 >160 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025, 10:12 , 2233 ***ABPS 179 >175 GENERATED AT 10:12:35. PIIC IX: ICUSURV3; (B)(6) 2025, 10:12 , 2233 SILENCE ICUSURV3; (B)(6) 2025, 10:12 , 2233 SILENCE ICUSURV3; (B)(6) 2025, 10:11 , 2233 **ABPS 165 >160 GENERATED AT 10:11:56. PIIC IX: ICUSURV3. BETWEEN 11:20AM AND 11:52AM THERE WERE ECG LEADS OFF MESSAGES, ACCOMPANIED BY PATIENT STRIPS BEING SAVED AND A PATIENT UPDATE. BETWEEN 17:49 AND 19:49, THE MONITOR WAS NOTED TO HAVE HAD THE ALARMS PAUSED, RESUMED AND SILENCED: (B)(6) 2025, 19:49 , 2223 SILENCE ICUSURV3; (B)(6) 2025, 19:46 , 2223 * IRREGULAR HR GENERATED AT 19:45:55. PIIC IX: ICUSURV3 (B)(6) 2025, 18:23 , 2223 RESUME ALL ALARMS M2223; (B)(6) 2025, 18:21 , 2223 SILENCE M2223; (B)(6) 2025, 18:21 , 2223 PAUSE ALL ALARMS M2223; (B)(6) 2025, 17:51 , 2223 RESUME ALL ALARMS M2223 ; (B)(6) 2025, 17:49 , 2223 SILENCE M2223; (B)(6) 2025, 17:49 , 2223 PAUSE ALL ALARMS M2223 . AN EXTREME TACHY (XTACHY) ALARM WAS NOTED TO HAVE OCCURRED AND HAD BEEN SILENCED AT THE SAME TIME THAT ALL ALARMS WERE PAUSED AT 21:37 WITH ALARM RESUME AT 21:39: (B)(6) 2025 21:39 2223 RESUME ALL ALARMS M2223; (B)(6) 2025 21:37 2223 ***XTACHY 148>140 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025 21:37 2223 PAUSE ALL ALARMS M2223; (B)(6) 2025 21:37 2223 SILENCE M2223; (B)(6) /2025 21:36 2223 **HR 134 >120 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025 21:36 2223 ***XTACHY 141>140 GENERATED AT 21:36:34. PIIC IX: ICUSURV3 BETWEEN 22:04 ON (B)(6) 2024 AND 02:03 AM ON (B)(6) 2025 THERE WERE MULTIPLE ALARMS, WHICH HAD BEEN SILENCED. AT 02:04 THERE WAS AN EXTREME BRADY (XBRADY) ALARM. THERE WAS AN ECG LEADS OFF MESSAGE GENERATED AT 2:03:47 AND IT WAS SEEN THAT ALARMS WERE TURNED OFF FOR PULSE - ECG/ARRHY ALARMS OFF AND ECG/ARRHYTHMIA ALARMS OFF; THE XBRADY ENDED AT 02:04AM. A RED TACHICARDIA (TACHY) ALARM AFTER THE XBRADY ENDED. THE PULSE - ECG/ARRHY AND ECG/ARRHYTHMIA ALARMS WERE TURNED BACK ON, ALONG WITH THE ECG LEADS OFF ENDING AT 02:05AM (B)(6) 2025 2:05 2223 ECG/ARRHYTHMIA ALARMS ON M2223; (B)(6) 2025 2:05 2223 ECG LEADS OFF ENDED. PIIC IX: ICUSURV3; (B)(6) 2025 2:05 2223 PULSE - ECG/ARRHY ALARMS ON M2223; (B)(6) 2025 2:04 2223 ***TACHY/P 242>140 GENERATED AT 02:04:06. PIIC IX: ICUSURV3; (B)(6) 2025 2:04 2223 * NON-SUSTAIN VT ENDED. PIIC IX: ICUSURV3; (B)(6) 2025 2:04 2223 ***XBRADY 32 <40 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025 2:04 2223 ECG/ARRHYTHMIA ALARMS OFF M2223; (B)(6) 2025 2:04 2223 PULSE - ECG/ARRHY ALARMS OFF M2223; (B)(6) 2025 2:04 2223 ECG LEADS OFF GENERATED AT 02:03:47. PIIC IX: ICUSURV3; (B)(6) 2025 2:04 2223 **HR 43 <50 ENDED. PIIC IX: ICUSURV3; (B)(6) 2025 2:04 2223 ***XBRADY 38 <40 GENERATED AT 02:03:40. PIIC IX: ICUSURV3. MULTIPLE ALARMS, INCLUDING RED TACHY, VENTRICULAR FIBRILLATION (VENT FIB), CENTRAL VENOUS PRESSURE (CVPM) ALARMS, AND LOWER LEVEL ALARMS WERE SEEN FROM 02:05AM THROUGH 07:29AM WITH MULTIPLE INSTANCES OF THE ALARMS BEING SILENCED AND PAUSED, AND THEN THERE WAS A PATIENT UPDATE AT 08:32AM. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS RELATED TO USER WORKFLOW. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. 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

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT A PATIENT REQUIRED RESUSCITATION DUE TO THE ALARMS BEING TURNED OFF. THE ICU STAFF TURNED OFF ALARMS FOR ART, PULSE, SPO2, AND RESP AND THE CUSTOMER REQUESTED ASSISTANCE REVIEWING THE AUDIT LOGS TO DETERMINE THE TIMING OF THIS ACTION. IT WAS INDICATED THE PATIENT WAS RESUSCITATED AND WAS CURRENTLY BEING MONITORED. THE ICU MANAGER LATER INDICATED THE PATIENT WAS NOT HARMED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED TO PROVIDE CLARIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575506 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention