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	Low Oxygen Saturation (2477)
Date of Event	12/02/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report was reported under incorrect registration number, please refer to 9610816-2026-100641 for further information regarding this complaint.
Event or Problem Description
It was reported the monitor did not generate an alarm for an spo2 desat and the patient passed away.The patient, who was status post tracheostomy, was seen for the evening assessment and medications at 2036.Respiratory therapy rounded on the patient at 2143 and performed suctioning and the patient demonstrated being able to suction around the tracheostomy independently as well.Patient was found at 2217 by nursing in an unresponsive state with agonal breathing.Resuscitation began but was unsuccessful and time of death was noted at 2231.The patient had been monitored with spo2 only prior to the event but there was no alarm generated.The customer performed a functional check of the device, revealing no issues; therefore, the customer requested assistance with the clinical audit logs to investigate this event.There were no previous issues with the device and the patient had already been admitted for 6 days.The patient was alert and oriented with no behavior concerns.The unit was set up as follows per the customer "this is our medical/surgical floor with bedside monitors that directly flow into epic.There is also a main monitor at the nurse¿s station.There would be no specific monitor tech as this patient was only on pulse oximetry so the nurses would be responsible for the alarms.Bedside monitors and nurses station monitors alarm for the specific set criteria and those parameters are not changed.".
Additional Manufacturer Narrative
A philips field service engineer (fse) went onsite and found that based on the system and monitor logs, no issues were reported.The fse also tested and verified that the monitor is functioning properly with no observed issues.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.

• 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: 23966669
• Report Number: 1218950-2026-100000
• Device Sequence Number: 11983926
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645(10)B.02.12
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/01/2026

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: 12/12/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2018
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 85 KG