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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
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 burn marks on axis z of gradient coil.During scan, an user message displayed smoke detector alarm.Upon opening the rear cover, a visual inspection revealed burn marks on the axis z busbar connected to the gradient coil.No harm was reported related to this incident.Based on this evidence it was decided to report this incident.
Additional Manufacturer Narrative
24-sept-2025 (b)(6) (complaint handling and vigilance reporting specialist) initial emdr report for the same issue, same system, same srn and same event date is submitted with (b)(6).The follow up report will be supported under (b)(6).
Additional Manufacturer Narrative
Initial emdr report for the same issue, same system, same srn and same event date is submitted with mfr report number: 3003768277-2025-010431.The follow up report submitted on 28-nov-2025, under mfr report number: 3003768277-2025-010431 (follow up: # 001).

• 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: 23071146
• Report Number: 3003768277-2025-010215
• Device Sequence Number: 13261164
• 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,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: 08/22/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 11/03/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/25/2025; 11/28/2025
• 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