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	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the intellispace cardiovascular (iscv) indicating that the user was unable to download either an anonymized or a non-anonymized study.The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint (b)(4).Philips has started an investigation of this complaint.

• 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: 50839161
• Report Number: 3003768277-2026-101602
• Device Sequence Number: 18654701
• Product Code: LLZ
• UDI-Device Identifier: 00884838122000
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 08/28/2026
• Initial Report FDA Received Date: 09/21/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown