MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported a desaturation alarm was not generated after the patient's condition met desat criteria, which led to a delay in care and subsequent patient death.The alleged failure to alarm was for both visual and audible alarms.During an onsite visit, engineering reviewed the alarm configuration, revealing the yellow alarm settings were set for a 10-second delay and the desat alarm was set for <80% with a 20-second delay.There is a pic ix central station with three overview stations being monitored by a single technician in this dedicated cmu department.There are an additional three technicians monitoring approximately three overview stations per technician in the same space.The overview was functional with audible alarm tones and red desat alarms working on currently monitored patients.The speaker was functioning as expected also, though it was an older model; however, it was noted the speaker was not mounted and was lying face down at the rear of the technician's desk.The following was noted on further investigation of the speaker, ".Noted it is installed without a speaker extender and is plugged directly into the back of pc 5t-overview.This pc is installed in a data rack in an adjoining room.The speaker was modified for this installation as the speaker wires were cut and spliced back together near the pc.With the assistance of biomed, we checked the specific functioning of the desat alarm in room 572.Biomed simulated a desat condition at the bedside monitor (b)(6) while i observed from the cmu.I noted the desat alarm functioned correctly by initiating 20 seconds after the start of the simulation.The alarm was audibly heard and visually present at the cmu technician workstation".Engineering requested logs and other data; however, some data was not available due to the time that passed since the event occurred.Vital sign data in one minute increments was then requested for review, but the customer has not supplied this information yet.
Additional Manufacturer Narrative
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
Device logs were received, and a philips product support engineer (pse) worked with philips clinical to review the logs.Per the pse, the logs show that the spo2 89<90 was generated at 13:41:46.The spo2 continued to drop and a desat 76<80 was generated at 13:43:41 ending the low spo2 alarm.This alarm was acknowledged at the pic ix (5tsurv) at 13:44:27.The monitor re-alarmed at 13:47:33.At 13:52:35, a xbrady 39<40 was generated which progressed to an asystole at 13:56:05.At 13:58:38, the alarms were acknowledged at the monitor (5tmon572).At 13:58:40, the desat alarm ended with the maximum deviation of 47.Date bed label action device name (b)(6) 2025 11:27:54 d572-1 run pvcs high generated at 11:27:42.Piic ix: 5tsurv (b)(6) 2025 11:30:55 d572-1 run pvcs high ended.Piic ix: 5tsurv (b)(6) 2025 13:35:01 d572-1 hr 48 <60 generated at 13:34:49.(hr = 87) piic ix: 5tsurv (b)(6) 2025 13:38:00 d572-1 hr 48 <60 ended.Piic ix: 5tsurv (b)(6) 2025 13:41:59 d572-1 spo2 89 <90 generated at 13:41:46.Piic ix: 5tsurv (b)(6) 2025 13:43:54 d572-1 desat 76 < 80 generated at 13:43:41.Piic ix: 5tsurv (b)(6) 2025 13:43:55 d572-1 spo2 76 <90 ended.Piic ix: 5tsurv (b)(6) 2025 13:44:27 d572-1 silence 5tsurv (b)(6) 2025 13:46:42 d572-1 hr 47 <60 generated at 13:46:29.(hr = 47) piic ix: 5tsurv (b)(6) 2025 13:47:33 d572-1 realarm 5tmon572 (b)(6) 2025 13:47:54 d572-1 run pvcs high generated at 13:47:42.Piic ix: 5tsurv (b)(6) 2025 13:47:55 d572-1 hr 42 <60 ended.Piic ix: 5tsurv (b)(6) 2025 13:49:42 d572-1 hr 41 <60 generated at 13:49:29.(hr = 41) piic ix: 5tsurv (b)(6) 2025 13:49:43 d572-1 run pvcs high ended.Piic ix: 5tsurv (b)(6) 2025 13:52:47 d572-1 xbrady 39 <40 generated at 13:52:35.(hr = 39) piic ix: 5tsurv (b)(6) 2025 13:52:48 d572-1 hr 40 <60 ended.Piic ix: 5tsurv (b)(6) 2025 13:56:17 d572-1 asystole generated at 13:56:05.(hr = 0) piic ix: 5tsurv (b)(6) 2025 13:56:18 d572-1 xbrady 37 <40 ended.Piic ix: 5tsurv (b)(6) 2025 13:58:38 d572-1 silence 5tmon572 (b)(6) 2025 13:58:40 d572-1 desat 47 < 80 ended.Piic ix: 5tsurv (b)(6) 2025 14:03:17 d572-1 asystole ended.Piic ix: 5tsurv.The customer stated that ¿this event is not equipment related¿.Based on the information provided, the reported problem was not confirmed.The device was confirmed to be operating by design.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 23622084
• Report Number: 1218950-2025-000693
• Device Sequence Number: 21100376
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645(10)B.02.18
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K153702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG