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

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Codes	Asystole (4442); Insufficient Information (4580)
Date of Event	07/12/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported there was a death of a patient because the customer did not receive an alarm.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
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.Reporting institution phone number: (b)(6).
Additional Manufacturer Narrative
A remote support engineer (rse) logged in remotely and viewed the clinical audit logs at the time of the event.There were multiple red alarms generated during the time of the event.Additionally, multiple technical alarms were generated during the time of the event as well.A philips product support engineer (pse) investigated the logs and confirmed the device operated as intended and generated red alarms as well as technical alarms during the time of the event.A philips clinical product specialist (cps) reviewed the logs and configuration file of the patient monitor.The cps determined the monitor volume was set 1 with the possibility of going to 0.The cps stated alarm latching is off for audible and visual, meaning alarms could generate, play alarm very briefly and stop without user interaction.With the alarm volume at 1, it could be perceived that there was a delay when a brief alarm generates and plays a sound.The alarm stops because the alarm condition ended and then alarm generated again, this alarm lasting longer was noticed giving the impression that it was delayed.Most alarms in this case were generated and ended within 1-5 seconds, sometimes even in the same second.The cps concluded the device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 22797519
• Report Number: 1218950-2025-000463
• Device Sequence Number: 18345191
• Product Code: MHX
• UDI-Device Identifier: 00884838112070
• UDI-Public: (01)00884838112070(10)4.1.0.0
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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?: 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: 07/15/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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