BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE PATIENT MONITOR MX750

    MDR report key: 22817285 · Received August 15, 2025

    Report

    Report Number
    9610816-2025-000753
    Event Type
    Death
    Date Received
    August 15, 2025
    Date of Event
    May 2, 2025
    Report Date
    September 16, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838083332
    PMA / PMN Number
    K210906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT WAS REPORTED, THE PATIENT EXPERIENCED A CARDIAC ARREST LIKELY CAUSING BRAIN DAMAGE. IT WAS CONFIRMED THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION PROVIDED INDICATES THE USERS WERE AWARE OF THE PATIENT'S CONDITION AT THE TIME OF THE EVENT; HOWEVER, THE CAUSE OF DEATH REMAINS UNKNOWN. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE INFORMATION PROVIDED (NO DEVICE LOGS OR CONFIGURATION PROVIDED/AVAILABLE) AND DETERMINED THE FOLLOWING: PER PIC IX AUDIT LOG. THE AFFECTED MONITOR (MX750 DE71321453) ALARMED SEVERAL TIMES FOR EXTREME TACHY (***XBRADY), HEART RATE LOW (**HR LOW) AND SPO2 DESATURATION (***SPO2 DESAT) IN THE GIVEN TIMEFRAME. THESE ALARMS WERE ALL ACKNOWLEDGED AT THE BEDSIDE DEVICE. 5/2/2025 19:48 CH528 **FC 99 <100 COMPLETED. PIC IX: PICIX_USC 5/2/2025 19:48 CH528 ***XBRADY 77 <80 GENERATED AT 19:48:48. PIC IX: PICIX_USC 5/2/2025 20:12 CH528 LL CONTACT FAILURE COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:12 CH528 !! ECG DEFCONTACTS GENERATED AT 20:12:32. PIC IX: PICIX_USC 5/2/2025 20:12 CH528 !! ECG DEFCONTACTS COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:12 CH528 LL CONTACT FAULT GENERATED AT 20:12:37. PIC IX: PICIX_USC 5/2/2025 20:12 CH528 ECG NOISESIGNAL GENERATED AT 20:12:44. PIC IX: PICIX_USC 5/2/2025 20:12 CH528 ECG NOISESIGNAL ENDED. PIC IX: PICIX_USC 5/2/2025 20:13 CH528 LL CONTACT FAILURE COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:13 CH528 !! ECG DEFCONTACTS GENERATED AT 20:13:19. PIC IX: PICIX_USC 5/2/2025 20:14 CH528 SPO2 NOPULSE GENERATED AT 20:13:50. PIC IX: PICIX_USC 5/2/2025 20:14 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:14 CH528 !! ECG DEFCONTACTS COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:14 CH528 CONTACT DEF MANAGER COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:14 CH528 RL CONTACT FAULT GENERATED AT 20:14:15. PIC IX: PICIX_USC 5/2/2025 20:16 CH528 ACKNOWLEDGE 123211 5/2/2025 20:16 CH528 ***XBRADY 77 <80 COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:16 CH528 **FC 90 <100 GENERATED AT 20:15:51. PIC IX: PICIX_USC 5/2/2025 20:16 CH528 ACKNOWLEDGE 123211 5/2/2025 20:16 CH528 **FC 90 <100 COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:16 CH528 **FC 99 <100 GENERATED AT 20:16:13. PIC IX: PICIX_USC 5/2/2025 20:25 CH528 **FC 91 <100 COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:25 CH528 ***XBRADY 76 <80 GENERATED AT 20:25:38. PIC IX: PICIX_USC 5/2/2025 20:31 CH528 ACKNOWLEDGE 123211 5/2/2025 20:31 CH528 ***XBRADY 76 <80 COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:31 CH528 **FC 87 <100 GENERATED AT 20:30:50. PIC IX: PICIX_USC 5/2/2025 20:31 CH528 **FC 87 <100 COMPLETED. PIC IX: PICIX_USC 5/2/2025 20:31 CH528 ***XBRADY 76 <80 GENERATED AT 20:31:33. PIC IX: PICIX_USC 5/2/2025 21:03 CH528 SPO2 INTERFERENCE GENERATED AT 21:02:52. PIC IX: PICIX_USC 5/2/2025 21:03 CH528 ACKNOWLEDGE 123211 5/2/2025 21:03 CH528 ***XBRADY 74 <80 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:03 CH528 RESP DEFCONTACTS GENERATED AT 21:03:44. PIC IX: PICIX_USC 5/2/2025 21:03 CH528 RL CONTACT FAILURE COMPLETE. PIC IX: PICIX_USC 5/2/2025 21:03 CH528 !! ECG DEFCONTACTS GENERATED AT 21:03:46. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 ACKNOWLEDGE 123211 5/2/2025 21:04 CH528 SPO2 INTERFERENCE ENDED. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 INTERFERENCE GENERATED AT 21:04:01. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 INTERFERENCE ENDED. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 NOPULSE GENERATED AT 21:04:15. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 INTERFERENCE GENERATED AT 21:04:34. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 INTERFERENCE ENDED. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 NOPULSE GENERATED AT 21:04:40. PIC IX: PICIX_USC 5/2/2025 21:04 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:05 CH528 SPO2 NOPULSE GENERATED AT 21:04:48. PIC IX: PICIX_USC 5/2/2025 21:05 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:05 CH528 **SPO2 92 <93 GENERATED AT 21:05:43. PIC IX: PICIX_USC 5/2/2025 21:08 CH528 SPO2 NOPULSE GENERATED AT 21:08:07. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 CALLED BACK. 123211 5/2/2025 21:09 CH528 ACKNOWLEDGE 123211 5/2/2025 21:09 CH528 **SPO2 92 <93 FINISHED. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 *** DESAT 6 < 88 GENERATED AT 21:09:08. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 SPO2 NOISESIGNAL GENERATED AT 21:09:09. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 ACKNOWLEDGE 123211 5/2/2025 21:09 CH528 *** DESAT 6 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 *** DESAT 2 < 88 GENERATED AT 21:09:14. PIC IX: PICIX_USC 5/2/2025 21:09 CH528 ACKNOWLEDGE 123211 5/2/2025 21:10 CH528 *** DESAT 0 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:10 CH528 SPO2 NOPULSE GENERATED AT 21:10:11. PIC IX: PICIX_USC 5/2/2025 21:11 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:11 CH528 SPO2 NOISESIGNAL GENERATED AT 21:11:06. PIC IX: PICIX_USC 5/2/2025 21:11 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:11 CH528 SPO2 ERRATIC GENERATED AT 21:11:13. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 SPO2 NOISESIGNAL GENERATED AT 21:11:52. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 SPO2 ERRATIC GENERATED AT 21:11:59. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 *** DESAT 0 < 88 GENERATED AT 21:12:10. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 ACKNOWLEDGE 123211 5/2/2025 21:12 CH528 *** DESAT 0 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 SPO2 NOPULSE GENERATED AT 21:12:17. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 *** DESAT 0 < 88 GENERATED AT 21:12:30. PIC IX: PICIX_USC 5/2/2025 21:12 CH528 ACKNOWLEDGE 123211 5/2/2025 21:12 CH528 *** DESAT 0 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 SPO2 ERRATIC GENERATED AT 21:12:52. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 *** DESAT 21 < 88 GENERATED AT 21:13:13. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 ACKNOWLEDGE 123211 5/2/2025 21:13 CH528 *** DESAT 5 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 SPO2 ERRATIC GENERATED AT 21:13:32. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 SPO2 NOPULSE GENERATED AT 21:13:35. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 *** DESAT 0 < 88 GENERATED AT 21:13:43. PIC IX: PICIX_USC 5/2/2025 21:13 CH528 ACKNOWLEDGE 123211 5/2/2025 21:14 CH528 *** DESAT 0 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:14 CH528 SPO2 ERRATIC GENERATED AT 21:14:13. PIC IX: PICIX_USC 5/2/2025 21:14 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:14 CH528 SPO2 NOPULSE GENERATED AT 21:14:25. PIC IX: PICIX_USC 5/2/2025 21:14 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:14 CH528 SPO2 ERRATIC GENERATED AT 21:14:45. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 SPO2 NOPULSE GENERATED AT 21:15:14. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 SPO2 ERRATIC GENERATED AT 21:15:24. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 SPO2 NOPULSE GENERATED AT 21:15:33. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 *** DESAT 0 < 88 GENERATED AT 21:15:41. PIC IX: PICIX_USC 5/2/2025 21:15 CH528 ACKNOWLEDGE 123211 5/2/2025 21:16 CH528 *** DESAT 0 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOISESIGNAL GENERATED AT 21:15:48. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOPULSE GENERATED AT 21:15:59. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOISESIGNAL GENERATED AT 21:16:04. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOPULSE GENERATED AT 21:16:08. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOISESIGNAL GENERATED AT 21:16:10. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 ERRATIC GENERATED AT 21:16:31. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 *** DESAT 58 < 88 GENERATED AT 21:16:38. PIC IX: PICIX_USC 5/2/2025 21:16 CH528 ACKNOWLEDGE 123211 5/2/2025 21:17 CH528 *** DESAT 2 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:17 CH528 SPO2 NOPULSE GENERATED AT 21:17:01. PIC IX: PICIX_USC 5/2/2025 21:17 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:17 CH528 SPO2 NOISESIGNAL GENERATED AT 21:17:02. PIC IX: PICIX_USC 5/2/2025 21:17 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:17 CH528 SPO2 NOISESIGNAL GENERATED AT 21:17:05. PIC IX: PICIX_USC 5/2/2025 21:17 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC 5/2/2025 21:17 CH528 SPO2 ERRATIC GENERATED AT 21:17:45. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 *** DESAT 23 < 88 GENERATED AT 21:17:58. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 ACKNOWLEDGE 123211 5/2/2025 21:18 CH528 *** DESATURATION 14 < 88 FINISHED. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 SPO2 ERRATIC GENERATED AT 21:18:16. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 SPO2 ERRATIC ENDED. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 *** DESAT 0 < 88 GENERATED AT 21:18:26. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 ACKNOWLEDGE 123211 5/2/2025 21:18 CH528 *** DESAT 0 < 88 COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:18 CH528 SPO2 NOPULSE GENERATED AT 21:18:32. PIC IX: PICIX_USC 5/2/2025 21:20 CH528 SPO2 NOPULSE COMPLETED. PIC IX: PICIX_USC 5/2/2025 21:20 CH528 SPO2 NOISESIGNAL GENERATED AT 21:20:19. PIC IX: PICIX_USC 5/2/2025 21:21 CH528 SPO2 NOISE SIGNAL OVER. PIC IX: PICIX_USC ALTHOUGH THE MONITOR LOGS WERE NOT AVAILABLE, THE CLINICAL AUDIT LOGS FROM THE PIC IX WERE REVIEWED. THE ANALYSIS OF THE AVAILABLE INFORMATION CONCLUDED THE DEVICE WAS OPERATING AS SPECIFIED. THE LOGS CONFIRM SEVERAL ALARMS FOR EXTREME BRADYCARDIA, LOW HEART RATE, AND DESATURATION, WHICH WERE ALL ACKNOWLEDGED AT THE BEDSIDE. THE LOGS CONFIRMED THE ALARMS WERE BEING MANAGED AT THE BEDSIDE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    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. REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WENT INTO CARDIAC ARREST AFTER BRADYCARDIA AND DESATURATION, BUT THE MONITOR DID NOT GENERATE ALARMS AS EXPECTED. IT WAS INDICATED THE MONITOR WAS NETWORKED WITH A CENTRAL STATION WHERE ALARMS WERE ON AND AUDIBLE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED. PREVIOUS INFORMATION OBTAINED INDICATED THE CENTRAL STATION PROVIDED ALARMS AND PATIENT HARM WAS MARKED AS NO. THE OUTCOME FOR THE PATIENT WAS INDICATED AS LIKELY BRAIN DAMAGE. THIS NEW INFORMATION INDICATED THE NURSES DID NOT RESPOND TO THE ALARMS AT THE CENTRAL STATION, WHICH RESULTED IN A DELAY IN CARE; HOWEVER, IT WAS ALSO NOTED THE CARDIAC ARREST WAS WITNESSED BY NURSING STAFF. IN ADDITION, IT REMAINED UNCLEAR WHETHER THE USER WAS SIMPLY WONDERING WHY THERE WERE NO ALARMS AT THE BEDSIDE WHEN ALARMS WERE OCCURRING AT THE CENTRAL STATION; HOWEVER, THE CUSTOMER ALSO INDICATED THE PATIENT HARM WAS 'MOST LIKELY' RELATED TO THE LACK OF BEDSIDE ALARM. BASED ON THE CONTRADICTORY INFORMATION RECEIVED, IT CANNOT BE DETERMINED WHETHER THE ALLEGED DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED DEATH. ADDITIONAL DATA HAS BEEN RECEIVED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787861 INTELLIVUE PATIENT MONITOR MX750 INTELLIVUE MX750 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX750 00884838083332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death