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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips identified a software defect in the iscv (intellispace cardiovascular) system wherein image data was not ready for stress studies.The device was in clinical use at the time of event.Based on the new information that philips became aware, this has been determined to be a reportable malfunction.Under specific circumstances, it could potentially lead to delayed diagnosis.Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, it is determined that this constitutes 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: 50802441
• Report Number: 3003768277-2026-101572
• Device Sequence Number: 8644205
• Product Code: LLZ
• UDI-Device Identifier: 00884838106970
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Report Date (Section B): 09/17/2026

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: 06/10/2025
• Initial Report FDA Received Date: 09/17/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown