MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

Model Number	4.2
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the alarms are not coming through.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) had the customer confirm there was no tone from the central station speaker.Rse instructed the customer to check all connections from speaker to sender.The customer rebooted the central station, and now the sound tone can be heard.The nursing staff pointed out some alarms were not heard correctly.The rse reached out to the customer who stated the technician was not hearing alarms from just one of the displays.The technician noted they can see the alarms but not hear them.The rse recollects the external speaker for the other display was working.Visually there were no disconnected wires.The rse remoted into their system and everything looked correct.System configurations for all red, yellow, and blue alarms were checked, and enabled for "audible at central".The customer did some testing with his simulator and results showed they were able to hear yellow and red alarms; however, it's the blue background in the sector they could not hear.The rse explained when an alarm occurred, the background turned blue in the sector as a visual alert.They should hear the reason or the alarm that caused it to turn blue.The customer was referring to this as a blue alarm.A good faith effort will be sent for further clarification regarding the blue audible alarms.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.
Additional Manufacturer Narrative
The following functional tests were performed: a philips remote service engineer (rse) had the customer confirm there was no tone from the central station speaker.Rse instructed the customer to check all connections from speaker to sender.The customer reboots the central station, and now sound tone can be heard.However, nursing staff said some alarms were not heard correctly.A philips clinical application specialist (cas) reached out to the customer who stated the technician was not hearing alarms from just one of the displays.The technician noted they can see the alarms but not hear them.The rse recollects the external speaker for other display is working.Visually there were no disconnected wires.The rse remoted into their system, and everything looked correct.System configurations for all red, yellow, and blue alarms were checked, and enabled for "audible at central".The rse explained when an alarm occurs, the background turns blue in the sector as a visual alert.The rse had the customer test the mx40 and hook it up to a simulator in the department, results of the testing showed they were able to get and hear the red and yellow alarms.The rse emailed a copy of the instructions for use (ifu) (pg 6-1 through 6-28), everything about the alarms and alarm behavior.The cas tried doing an audit log check with the customer; however, remoting into their system was not possible.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed as the issue could not be replicated.The reported problem was not confirmed.The investigation concludes that no further action is required at this time.No further investigation or action is warranted.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: 22751080
• Report Number: 9610816-2025-000723
• Device Sequence Number: 8715856
• Product Code: MHX
• UDI-Device Identifier: 00884838121782
• UDI-Public: (01)00884838121782(10)4.2.4.0
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 4.2
• Device Catalogue Number: 866389
• Device Lot Number: 4.2.4.0
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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
• Patient Sex: Unknown