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

Model Number	SMARTPATH TO DSTREAM FOR 1.5T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a male patient was undergoing a simple lumbosacral spine mri under general anesthesia, with a duration of 30 minutes.At the time of the incident, the patient sustained a skin injury, a laceration while entering the achieva (d stream) resonator.It had occurred due to the absence of the quadrature body coil sealing adhesive.Despite the use of an arm support, the injury is observed with redness and traces of blood.The injury was located on the right forearm, distal middle third, and the size of the wound is reported as less than 1 cm.A nursing assistant cleaned the area with saline solution and, once dry, applied fatty acids (linovera topical solution).The wound is expected to heal completely and the patient remained stable.The reported injury meets the criteria for a minor non-serious injury, and the treatment administered is considered first aid.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was the bore seal issue.The qbc seal that was missing was installed and the system was handed back to the customer for use.
Event or Problem Description
Philips received a report that a male patient sustained a skin injury, a laceration while entering the achieva (d stream) resonator.The incident occurred due to the absence of the quadrature body coil sealing adhesive.This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the magnet covers.If this seal is missing it is likely that this could lead to serious injury.The injury is observed with redness and traces of blood.The injury was located on the right forearm, distal middle third, and measured less than 1 cm.A nursing assistant cleaned the area with saline solution and, once dry, applied fatty acids (linovera topical solution).The wound is expected to heal completely and the patient remained stable.No photograph was available for assessment.At the time of the incident, the patient was undergoing a simple lumbosacral spine mri under general anesthesia, with a duration of 30 minutes.The reported injury meets the criteria for a minor non serious injury, and the treatment administered is considered first aid.

• 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: 24566805
• Report Number: 3042177665-2026-000010
• Device Sequence Number: 8384539
• Product Code: LNH
• UDI-Device Identifier: 00884838095076
• UDI-Public: 00884838095076
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063559
• 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
• Report Date (Section B): 03/11/2026

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: SMARTPATH TO DSTREAM FOR 1.5T
• Device Catalogue Number: 781260
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/11/2026
• 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: 2023-PD-MR-013
• Patient Sequence Number: 1
• Patient Sex: Male