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	Computer System Security Problem (2899)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the customer is experiencing performance issues and a network threat was detected.The device was in clinical use at the time of the event and no adverse events or harm were reported.Philips has started an investigation for this complaint.
Additional Manufacturer Narrative
It was reported to philips that the customer is experiencing performance issues and a network threat was detected.The device was in clinical use at the time of the event and no adverse events or harm were reported.The complaint contained no allegation of serious injury or death.The problem was unable to be replicated.Checks on the server were performed and no issue was found.Customer confirmed that system is performing normally.Based on the results of the analysis, iscv was confirmed to be operating per specifications.Based on the available information, this record is considered to be non-reportable.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: 24966550
• Report Number: 3003768277-2026-101073
• Device Sequence Number: 20081686
• Product Code: LLZ
• UDI-Device Identifier: 00884838085770
• UDI-Public: (01)00884838085770(11)171207(10)2.3.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/21/2026

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: 830084
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/21/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown