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	Delayed Alarm (1011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a patient information center ix indicating that during observation a patient that should have been alarming during a brady episode had an alarm banner but did not have a blue alarm sector.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel which included review of configuration files.The results of the analysis showed the yellow alarms are not audibly latched.Alarm reminders are on, but not set to re-alarm and reminder time is set to 3 minutes.The rn reported that during observation a patient that should have been alarming during a brady episode had an alarm banner but did not have a blue alarm sector.This may indicate that the alarm was acknowledged at the bedside without the knowledge of the cmu.Additional information was requested from the rn regarding bed or patient id as well as precise times of the observations.The rn manager asserted that the monitors are not alarming as expected though no specific times were provided and with limited information, no fault could be found.A field service engineer when onsite to review audit logs and verify behavior; however, the customer was unable to provide an exact example of the issue.They reported that sometimes the spo2 goes red at 85 and sometimes it goes yellow instead of red.They were reporting this in the ed and the ed does not admit patients.The issue was not able to be observed or reproduced.The product malfunction was unable to be confirmed because the customer was unable to provide an exact example for review in the log and the issue was not able to be observed or reproduced.The customer was provided information regarding requests for configuration changes related to shortening buffer times between alarms.A review of the service history for this device shows the problem has not been reported again for this device.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 ; 70314632031
• MDR Report Key: 25469113
• Report Number: 9610816-2026-101124
• Device Sequence Number: 21315547
• Product Code: MHX
• UDI-Device Identifier: 00884838128880
• UDI-Public: (01)00884838128880(10)4.6.1.0
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/11/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2026
• 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
• Patient Sex: Unknown