MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLISPACE PERINATAL; SYSTEM, MONITORING, PERINATAL

Model Number	INTELLISPACE PERINATAL K LARGE ARCH.
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) contacted the customer site.The perinatal system set up was checked, the sound alarms of the user groups were enabled, and the speaker volume settings in the window was also verified; the patient alarms were still not heard.Configuration changes were made and the sound was then operating.The customer was contacted and confirmed that it is now operational.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a configuration issue.Configuration changes were made and the sound was then operating.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.If additional information is received, the complaint file will be reopened for further investigation.E1: reporting institution phone #: (b)(6).Reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on an intellispace perinatal k large arch indicating that the patient sound alarms do not work.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: INTELLISPACE PERINATAL
• Common Device Name: SYSTEM, MONITORING, PERINATAL
• 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: 25469939
• Report Number: 9610816-2026-101118
• Device Sequence Number: 13338975
• Product Code: HGM
• UDI-Device Identifier: 00884838084483
• UDI-Public: (01)00884838084483(10)K.00.11
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: 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: 05/25/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2019
• 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
• Patient Sex: Unknown