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	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the patient information center ix indicating that the customer requested assistance obtaining the audit logs after the patient passed away.The patient was admitted at 1648 via medical record number.The audit logs revealed red technical inop alarms for ecg leads off occurred at 2222, and were acknowledged at 2225.The alarm reminder occurred approximately every 3 minutes until 2352.The patient coded at approximately 2330.
Additional Manufacturer Narrative
Analysis was performed by philips remote clinical support (rcs), who spoke to the customer.The audit logs revealed red technical inop alarms for ecg leads off occurred at 2222 and were acknowledged at 2225.The alarm reminders occurred approximately every 3 minutes until 2352.The patient coded at approximately 2330 and passed away.The manager requested assistance reviewing events leading up to the patient code.It was further indicated there were multiple admissions doing on at the time of the event.The audit log review revealed the user had not signed into the phone, so al alarms for telemetry were being sent to the phone and dropped due to this.The primary nurse eventually responded to the red technical inop alarms, but her phone was not receiving notifications due to the aforementioned sign in issue.In addition, it was noted there was no staff at the central station at this time.Based on the results of the analysis, the device was confirmed to be operating per specifications and no failure was identified.Philips senior clinical solution consultant went onsite and worked with the nurse manager.Showed the nurse manager how to use the audit logs at the pic.We were able to see that a red ¿leads off¿ alarm was announced at the pic, as well as several re-alarms (reminders).I also discussed with her ways to improve ecg signal on a patient (applying electrodes in the correct position, implementing good skin prep, changing electrodes at least every 24 hours, etc.).A review of the service history for this device shows there have been no additional issues reported related to this device.

• 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 ; 70314632031
• MDR Report Key: 24954971
• Report Number: 9610816-2026-100757
• Device Sequence Number: 17453338
• Product Code: MHX
• UDI-Device Identifier: 00884838122772
• UDI-Public: (01)00884838122772(10)4.3.1.0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/22/2026

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: 03/24/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 148 KG