MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	INGENIA ELITION X
Medical Device Problem Codes	Sparking (2595); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has started an investigation; a follow up report will be submitted once the investigation has been completed.
Event or Problem Description
Philips received a report about broken busbar.During scanning a gradient error caused an interlock.Based on this evidence, the incident was reported.It was found that the busbar of z axis was burned and broken.No harm was reported related to this incident.Based on this evidence it was decided to report this incident.
Additional Manufacturer Narrative
Based on the on the investigation performed, the cause found related to failure of busbar on wb30s system.The smoke detector was activated which led to the system halting its scanning operation.The system's built-in mitigation measures functioned as intended by initiating a shutdown in response to the failure.This preventive action effectively stopped the malfunction from escalating into a safety issue.The risk of fire/smoke in examination or technical room caused by compromised electrical contact in current carrying part of the gradient chain, is identified in the risk management matrix as hazard gr.15.In this case there is no reported that the patient or operator suffered an injury.The defective busbar was replaced at site and the system was back in use.

• Brand Name: INGENIA
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• 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: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 23060857
• Report Number: 3003768277-2025-010214
• Device Sequence Number: 10044039
• Product Code: LNH
• UDI-Device Identifier: 00884838098336
• UDI-Public: (01)00884838098336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K193215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: INGENIA ELITION X
• Device Catalogue Number: 782107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown