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	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips identified a software defect in intellispace cardiovascular (iscv) wherein the upgrade of intellispace cardiovascular (iscv) 4.1 to intellispace cardiovascular (iscv) 8.1 failed.The issue was identified outside of clinical use and no adverse events or harm were reported in the complaint ((b)(4)).Philips is currently updating the risk management matrix for the iscv product.Until this update is complete, and in an abundance of caution, philips is submitting a regulatory report for all iscv (intellispace cardiovascular) product malfunctions alleged in complaint investigations relating to data availability until the update of the risk management matrix is completed.
Additional Manufacturer Narrative
Philips identified a software defect in intellispace cardiovascular (iscv) wherein the upgrade of intellispace cardiovascular (iscv) 4.1 to intellispace cardiovascular (iscv) 8.1 failed.The issue was identified outside of clinical use and no adverse events or harm were reported in the complaint (b)(4).Based on the available information, there is no allegation of death or serious injury.The initial report was submitted as an abundance of caution since the iscv risk management matrix was undergoing an update.The risk assessment of the reported issue is performed and concluded that this issue would not be likely to cause or contribute to a death or serious injury if this were to recur and hence this issue is determined as non-reportable.

• 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: 23777105
• Report Number: 3003768277-2025-015671
• Device Sequence Number: 10091364
• Product Code: LLZ
• UDI-Device Identifier: 00884838093072
• UDI-Public: (01)00884838093072(10)4.1.0.0(11)190416
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2026

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: 11/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 05/17/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown