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

Model Number	INGENIA 3.0T CX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Unintended Loss of Vascular Access (4867)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
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 that upon the entry into the mri scanner for a pelvic scan, the patient is lying down with the anterior coil, feet forward.The patient grazed his nasal septum with the anterior coil.Described as a scratch from the coil's friction that did not require treatment.The patient had an iv line for contrast on unknown arm.Phlebitis occurred as a consequence of bending the arm at the site where the intravenous line was inserted.Subsequent treatment with sodium heparin administered to the area of phlebitis, as the coil, during movement, dislodged the venous access route.The patient's current status was reported as "fine on (b)(6) 2026".The study was performed on another mri scanner at the client location.The administration of sodium heparin to treat the reported phlebitis related to the iv being dislodged by the reported event, meets the criteria for a serious injury.
Event or Problem Description
Philips received a report that upon the entry into the mri scanner for a pelvic scan, the patient is lying down with the anterior coil, feet forward.The patient grazed his nasal septum with the anterior coil.Described as a scratch from the coil's friction that did not require treatment.The patient had an iv line for contrast on unknown arm.Phlebitis occurred as a consequence of bending the arm at the site where the intravenous line was inserted.Subsequent treatment with sodium heparin administered to the area of phlebitis, as the coil, during movement, dislodged the venous access route.The patient's current status was reported as "fine on jan 05 2026".The study was performed on another mri scanner at the client location.The administration of sodium heparin to treat the reported phlebitis related to the iv being dislodged by the reported event, meets the criteria for a serious injury.
Additional Manufacturer Narrative
There was no indication of a mr system malfunction identified which could have contributed to the incident.The log files were reviewed, and no errors were found on the reported date of the incident.It was concluded, that pinch points between tabletop and system covers (i.E., horizontal motions with long connections (in this case the coil cable) hanging over edge of tabletop) due to foreseeable (mis)use, was the most likely cause of this injury.

• 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: 24186924
• Report Number: 3003768277-2026-100392
• Device Sequence Number: 7975871
• Product Code: LNH
• UDI-Device Identifier: 00884838068452
• UDI-Public: (01)00884838068452
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown