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

Model Number	INGENIA 3.0T
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	12/16/2025
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 gradient amplifier rack fault.During scanning a gradient amplifier rack fault error was reported.A current error in z2 was seen and gc terminal was broken.Based on this evidence, the incident was reported.No harm was reported related to this incident.Based on this evidence it was decided to report this incident.
Event or Problem Description
Philips received a report about gradient amplifier rack fault.A current error in z2 was seen and gc terminal was broken.It was found that the gradient coil terminal got broken.The gradient coil was replaced with a new unit, followed by system ramp up and shimming.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 root cause of the issue is identified to be software issue.It was found that the customer is still operating on software release 5.3.Data analysis shows that the customer is scanning regularly in the regions that are considered as no fly zones in software releases after 5.3.For several years, the software has included these no fly zones specifically to prevent the type of failures observed at this site.The modeling that we did on potential damage without the no fly zones predicts that the z terminal is the most critical and crack initiation is highly likely.(y-scanning leads to breakage of z axis terminal/busbar).Improved no fly zones have been implemented in later software versions effectively prevent these failure modes.The continued scanning with the old software can trigger the onset of the next failure.Any damage that has already occurred cannot be reversed.We therefore strongly recommended to the customer to upgrade the software immediately, not only on the affected system but also on other similar systems.The issue was resolved at site with an installation of new gradient coil and the system was handed back to the customer for 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: 23863917
• Report Number: 3003768277-2025-015833
• Device Sequence Number: 18658651
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: (01)00884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: 3003768277
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: INGENIA 3.0T
• Device Catalogue Number: 781342
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/02/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2024-PD-MR-023
• Patient Sequence Number: 1
• Patient Sex: Unknown