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
Additional Manufacturer Narrative
Philips reviewed the reported complaint requesting iscv design such that there is no direct connection required to database from thick client.Based on the results of the investigation, it was determined that the iscv thick client is granted direct access to the product database, so an authenticated user can operate on patient and system data outside the application and thereby bypass application-level authorization checks and application-level audit record creation, including performing bulk actions beyond their application-level authorization.This vulnerability was found outside of clinical use during security testing, however, if exploited, based on the nature of actions performed by the attacker, there is potential for data corruption.A risk assessment was performed and concluded that this defect could allow an attacker to gain unauthorized access to the iscv database or patient data, potentially resulting in iscv becoming unavailable or patient data being corrupted.Under certain specific circumstances, this issue could potentially lead to delayed diagnosis or misdiagnosis.Based on this information, this is determined as a reportable malfunction.

• 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: 50649828
• Report Number: 3003768277-2026-101394
• Device Sequence Number: 18742846
• Product Code: LLZ
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 09/07/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown