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

Model Number	INGENIA 3.0T CX
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	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qbc seal that was broken was replaced and the system was handed back to the customer for use.The failure of the qbc seal to remain in place is considered a malfunction.Remedial action: a field action was initiated under 2023-pd-mr-013.A field safety notification was sent to the customers informing them about this potential issue.The field correction has since been made available to the field in dec 2024.
Event or Problem Description
Philips received a report that the quadrature body coil (qbc) seal was broken.This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the magnet covers.If this seal is broken it is likely that this could lead to serious injury.
Additional Manufacturer Narrative
The reported issue is not related to the qbc seal issue from the reportable malfunction list.It is related to the spare part required for the magnet quench event.Therefore we are sending a correction follow up report.It is concluded that this product problem does not pose an unacceptable risk to health to patients, users, or bystanders because if this product problem were to recur it would not be likely to cause or contribute to a death or serious injury.There is no harm reported in this case.Based on the available information, this issue has been determined not to be a reportable event.

• Brand Name: INGENIA 3.0T
• 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: 23476407
• Report Number: 3003768277-2025-014027
• Device Sequence Number: 16075893
• Product Code: LNH
• UDI-Device Identifier: 00884838068452
• UDI-Public: (01)00884838068452
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162931
• 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): 11/21/2025

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 CX
• Device Catalogue Number: 781271
• 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: 11/01/2025
• Supplement Date Received by Manufacturer: 11/01/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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: 2023-PD-MR-013
• Patient Sequence Number: 1
• Patient Sex: Unknown