MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2024
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported the alarms were silenced at the central station without clinician input.Nurses indicated no one at the central station silenced the alarms or touched the mouse, yet the alarms auto-silenced, per the customer.The customer's alarm configuration was unknown at the time of this assessment.Good faith efforts are ongoing.
Additional Manufacturer Narrative
A philips field service engineer (fse) evaluated the device and could not confirm the alarm issue.The clinical audit logs for the dates/times relevant to the investigation were not available.The engineer was unable to provide their analysis findings as we are unable to confirm the issue with the missing logs.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
As part of a preliminary hazard analysis (pha) performed by risk management and medical safety teams, this investigation was determined to be in need of review and update as needed.A supplemental report was deemed necessary.This report has been created with reference to mfg report # 1218950-2024-00626.The follow corrections have been made based on current information available: box a: patient information.Box b: adverse event/product problem.Box d: product brand name, model number, product udi.Box g: report source.Box h: manufacture date.Analysis was performed a philips field engineer which included functional testing and communication.The results of the analysis could not confirm the alarm issue.The clinical audit logs for the dates/times relevant to the investigation were not available.Based on the results of the analysis, the product malfunction was unable to be confirmed.Functional testing confirmed the system was working as intended during evaluation; however, the engineer was unable to provide their analysis findings as we are unable to confirm the issue with the missing logs.The cause of the issue remains unknown.A review of the service history for this device shows the problem has not been reported again for this device.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 20148688
• Report Number: 1218950-2024-00626
• Device Sequence Number: 20924969
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715(10)C.02.03
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163584
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 11/05/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 12/23/2024; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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