MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INTELLISPACE CARDIOVASCULAR; CARDIOVASCULAR IMAGE AND INFORMATION MANAGEMENT SYSTEM

Model Number	INTELLISPACE CARDIOVASCULAR
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that during one of the studies, the physiologist got an error in the iscv system and was not able to retrieve the measurements made on the study.The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
It was reported to philips that during one of the studies, the physiologist got an error in the iscv system and was not able to retrieve the measurements made on the study.The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint.Based on the results of the analysis, it was determined that the product has malfunctioned and the cause of the reported problem was a 'nan' (not a number) value in the xml sr file in the analysis inbox folder.Intellispace cardiovascular (iscv) generated an error as it was unable to process this value.As an immediate action, the issue was resolved by replacing the nan values with 0 (zero) and saved the report.Although no adverse events or patient harm were reported in the associated complaint, this malfunction has been determined to be reportable.Under specific circumstances, it could potentially lead to delayed diagnosis or misdiagnosis.Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, philips has determined that this constitutes a reportable malfunction.Note: evaluation results and conclusion fda c-code have been updated.

• Brand Name: INTELLISPACE CARDIOVASCULAR
• Common Device Name: CARDIOVASCULAR IMAGE AND INFORMATION MANAGEMENT SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: edita reznik-shmueli ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 24720892
• Report Number: 3003768277-2026-100989
• Device Sequence Number: 14974348
• Product Code: LLZ
• UDI-Device Identifier: 00884838095250
• UDI-Public: (01)00884838095250(11)191207(10)4.2.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K153022
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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
• Device Model Number: INTELLISPACE CARDIOVASCULAR
• Device Catalogue Number: 830089
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/27/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown