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	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips identified a defect in intellispace cardiovascular (iscv) in which a synchronization issue between the fetch and import processes (race condition) may occur when the study is offline, potentially leading to deletion of newly imported data following a fetch failure.The device was in clinical use at the time of the event.No adverse events or harm were reported in the complaint.This has been determined to be a reportable malfunction.Under specific circumstances, it could potentially lead to delayed diagnosis or misdiagnosis.Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, philips has 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: 24794206
• Report Number: 3003768277-2026-101039
• Device Sequence Number: 18344451
• Product Code: LLZ
• UDI-Device Identifier: 00884838095250
• UDI-Public: (01)00884838095250(11)191207(10)4.2.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 04/06/2026

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): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/06/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown