MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	INGENIA 3.0T R5 BASED
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report that a gradient rack fault occurred.Upon closure inspection it was found that the zb+ terminal was broken.No harm was reported.
Additional Manufacturer Narrative
Philips has started an investigation.A follow up/final report will be submitted once completed.
Additional Manufacturer Narrative
An investigation was performed on all the available data and the following was concluded.This is a terminal (connection) failure of a wa30s coil of the first generation that has m10 bolt connections.It is the result of a fatigue process caused by the vibrations of the system.These failures have already led to design improvements such as smaller m8 holes in the terminal connection and more sophisticated ""no-fly zones"" implemented in the system software that helps to avoid certain frequency domains thereby minimizing vibrations.The gradient coil was replaced by the improved model containing the m8 bolt connections and the system was returned to use.

• Brand Name: INGENIA 3.0T
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 21616750
• Report Number: 3003768277-2025-002561
• Device Sequence Number: 15129983
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: (01)00884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 3.0T R5 BASED
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/22/2025
• 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