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	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips identified an internal software defect in the intellispace cardiovascular (iscv) system whereby server message block (smb) signing is not mandatorily enforced on remote hosts.There is no allegation of death, serious injury, or adverse event associated with this issue.This security weakness could allow an attacker with prior access to the iscv network to intercept or manipulate communications between systems, potentially leading to unauthorized access to sensitive patient information (phi/pii), modification of image repository files, or other unauthorized file operations.Under certain circumstances, compromised medical images or patient data could be relied upon for clinical decision-making, potentially resulting in misdiagnosis, delayed or missed critical findings.Therefore, although the issue was identified internally and exploitation requires prior network access, the potential impact on the integrity of diagnostic information and subsequent clinical decision-making supports classification of this issue 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: 50897781
• Report Number: 3003768277-2026-101627
• Device Sequence Number: 5853027
• Product Code: LLZ
• UDI-Device Identifier: 00884838125773
• UDI-Public: (01)00884838125773(11)251114(10)9.2.0.0
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K251215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 01/20/2025
• Initial Report FDA Received Date: 09/25/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown