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	Sparking (2595); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report about a failure of the gradient coil which caused artifacts.During replacement burn evidence was found at the point of the terminal connection.Based on this burn evidence it was decided to report this incident.No harm was reported related to 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 available information and data an investigation was performed.It was found that there was some kind of sparking/short between the x and y coil at the terminal region.It was determined that the product has malfunctioned and the most likely cause of the reported problem was a failure of the conductive path in the gradient chain.This issue corresponds to the c&r 2024-pd-mr-023, which has corrective actions defined for the system affected in this case.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: 20664249
• Report Number: 3003768277-2024-06487
• Device Sequence Number: 7239210
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 00884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163116
• 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): 11/27/2025

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: 781341
• 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: 08/24/2024
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/27/2025
• 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
• 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