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	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
22-sep-2026, (b)(6): the gdts are reassessed as part of the correction task (b)(4) ¿ remediation of iscv complaints (capa#6506497).Philips identified a software defect in the iscv (intellispace cardiovascular) system wherein user faced conversion error.Although there was no adverse event associated, 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: 50853532
• Report Number: 3003768277-2026-101613
• Device Sequence Number: 15936706
• Product Code: LLZ
• UDI-Device Identifier: 00884838087460
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 830087
• 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: 01/26/2023
• Initial Report FDA Received Date: 09/22/2026
• 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