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	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that there was merging issue of images from the unnamed patient folder into another folder.The device was in clinical use at the time of event, and no adverse events or patient harm was reported in the associated complaint (b)(4).Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
It has been reported to philips that there was a merging issue of images from the unnamed patient folder into another folder.The device was in clinical use at the time of event, and no adverse events or patient harm was reported in the associated complaint (b)(4).Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem was a user workflow issue.The patient was not selected from the modality worklist resulting in the study being transferred with a generic id.Correction by updating the information in the modality and resending the study to iscv (intellispace cardiovascular) with the correct details was not possible as the study was already deleted in the modality.Service personnel transferred the images to the correct patient folder.Workflow guidance was provided to the customer to help prevent reoccurrence.Based on the available information, this record is considered to be non-reportable.Note: the evaluation results fda c-code and conclusion fda c-code have been updated in this emdr (b)(4).

• 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: 24766255
• Report Number: 3003768277-2026-101031
• Device Sequence Number: 13086231
• Product Code: LLZ
• UDI-Device Identifier: 00884838076730
• UDI-Public: (01)00884838076730(11)160920(10)1.2.3.0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061995
• 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,Followup
• Report Date (Section B): 04/29/2026

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: 830080
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown