MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH Patient Information Center iX; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	Patient Information Center iX
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2026
Type of Reportable Event	Death
Event or Problem Description
Philips received a complaint on a patient information center ix indicating the customer requested assistance obtaining information following the death of a telemetry patient.The clinical audit log was reviewed, revealing red alarms including asystole were generated prior to the ecg leadset becoming unplugged at 0925.After this, there was an ecg leads off alarm, an alarm pause, atrial fibrillation alarm then ended.The alarms were acknowledged at the surveillance, after which time there was no further information seen from this patient until 1905 when a tele battery low technical alarm was generated.The nurse indicated the patient was found unresponsive and pulseless sometime after 1800.Though the exact cause of the event remains unknown, the customer stated, 'they are not reporting that the issue was caused by the device and believe the issue was probably caused by nurses not replacing the tele pack batteries after receiving low battery notifications requiring replacement to continue monitoring'.Based on the information received, there does not appear to be a device malfunction that caused or contributed to the reported death; however, use issues related to alarm management and clinical workflow may have been factors.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included pulling the alarm logs and communication with the customer.The results of the analysis confirmed there was no issue with the philips equipment.Based on the results of the analysis, the product was confirmed to be operating per specifications and use issues related to alarm management and clinical workflow may have been factors in the event.The customer was provided with alarm logs as requested.Based on the information available and results of additional analysis, no further action is necessary at this time.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 Medizin Systeme Böblingen GmbH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): Philips Medizin Systeme Böblingen GmbH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; +49(703)14632031
• MDR Report Key: 50580697
• Report Number: 9610816-2026-101786
• Device Sequence Number: 13229740
• Product Code: MHX
• UDI-Device Identifier: 00884838122772
• UDI-Public: (01)00884838122772(10)4.3.2.0
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K211900
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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?: No
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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 Sex: Unknown