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	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2026
Type of Reportable Event	Death
Event or Problem Description
Philips received a complaint on a patient information center ix (pic ix) indicating the spo2 turns measurement turns off when the telemetry device battery is low and the patient passed away.The customer alleged partial responsibility to the telemetry system.The patient was found with bipap on their face but the bipap was not running with oxygen saturation in the 60s so a code was called.The patient was intubated and transferred to sicu.After the code, the customer reviewed the logs, revealing the patient's battery was in the red and had not been measuring spo2.It was determined when the telemetry battery was low, spo2 shuts down automatically.The customer was requesting this setting be changed if possible.A philips remote service engineer (rse) reviewed the clinical audit log, revealing a tele battery low technical alarm was generated at 01:08:50 and a "no spo2t, batt low' was generated at 01:19:12.The technical alarms were acknowledged at 02:00.Spo2t alarms were noted throughout the morning.A 'no data tele' technical alarm was generated at 07:53:11.The rse advised the customer biomedical engineer (biomed) that the spo2 will turn off after a low battery state is reached and the 'no spo2t, batt low' message will be announced.The rse also advised the biomed to change the battery low technical alarm to either red or yellow, instead of the currently configured cyan alarm.There was no device malfunction identified.
Additional Manufacturer Narrative
Based on the results of the analysis, it does not appear a device malfunction caused or contributed to the reported event.However, use issues related to clinical workflow or alarm management may have been factors.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.If additional information is received, the complaint file will be reopened for further investigation.

• 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 ; +1(617)245-5900
• MDR Report Key: 50497431
• Report Number: 1218950-2026-100584
• Device Sequence Number: 9431914
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041(10)C.03.08
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183387
• 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
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 147 LB