MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE PERINATAL; SYSTEM, MONITORING, PERINATAL

Model Number	INTELLISPACE PERINATAL K LARGE ARCH.
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by remote service engineer (rse) personnel which included logging in remotely and reviewed the pc configuration.The rse noticed that audible alarms were not enabled on the hl7 server.Verified alarm defaults and confirmed that real-time alerting was properly configured.Requested the customer to enable audible alarms; however, they were still not hearing any alerts.Checked system uptime and found the internal server had been running for 330 days, while the hl7 server had been up for 32 minutes.Recommended a reboot of the internal server.Customer approved the reboot.After the restart, the customer restarted the hl7 server, and audible alarms were successfully restored.Based on the results of the information available, the product was confirmed to be operating per specifications, and the cause of the reported problem is unknown.The customer rebooted the internal server, which resolved the alarm issue.A review of the service history for this device shows the problem has not been reported again for this device.
Event or Problem Description
Philips received a complaint on an intellispace perinatal k large arch.Indicating that they are not receiving heartrate alarms.The device was in use on a patient at time of event; there was no adverse event reported.

• Brand Name: INTELLISPACE PERINATAL
• Common Device Name: SYSTEM, MONITORING, PERINATAL
• 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: 25156625
• Report Number: 9610816-2026-100922
• Device Sequence Number: 15797361
• Product Code: HGM
• UDI-Device Identifier: 00884838084483
• UDI-Public: (01)00884838084483(10)K.00.11
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173941
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: INTELLISPACE PERINATAL K LARGE ARCH.
• Device Catalogue Number: 867061
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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
• Patient Sex: Unknown