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

Model Number	INGENIA 1.5T
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report of a gradient coil issue, indicating that there was a fire, on an adulterated mr system.The incident occurred after the system was removed from its original site and re-installed in a mobile trailer by an unauthorized third party, without philips¿ knowledge or involvement.No harm was reported related to this incident.Based on this evidence it was decided to report this incident.
Additional Manufacturer Narrative
Philips has started an investigation; a follow up report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
Based on the information available, the ingenia 1.5t mr system was installed in st.Cloud va in st.Cloud, minnesota/us and the customer notified philips of the removal of the system in may 2024.In august 2025, company imaging solutions inc.Reached out to philips and reported a fire in the gradient chain.The company altered the mr system as they installed it on a mobile trailer without knowledge and/or authorization by philips.The customer should return the system to original configuration and do not use the system until returned to original condition and iatd/system handover is performed.Based on the further investigation and risk assessment, this issue has been determined not to be a reportable event.

• 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: 22975596
• Report Number: 3003768277-2025-009044
• Device Sequence Number: 15696294
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 00884838009820
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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 1.5T
• Device Catalogue Number: 781396
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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