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

Model Number	SMARTPATH TO DSTREAM FOR XR AND 3.0T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754); Insufficient Information (4580)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No functional tests were performed as this issue was caused by a use error by bringing a non mr safe wheelchair into the examination room.Based on the provided information there is no indication of a malfunction of the mri system.The root cause of this incident is determined to be a use error.The user did not follow the instruction for use "ifu section magnet safety - access to controlled access area".It is a known issue that no magnetic materials should be brought into the examination room.
Event or Problem Description
Philips received a report that a wheelchair made up of ferrous material was brought into the mr room.The user was injured when the magnetic wheelchair became stuck while approaching the magnet.As a result, the user sustained bruises and abrasions.The user was sent to emergency department of hospital.The reported injury was superficial in nature, consisting only of minor abrasions and bruises, and full recovery is expected.The customer has chosen not to provide information regarding the user involved including region, size, or location of the injury, nor any information about the medical interventions provided.We have decide to report this event out of an abundance of caution.

• 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: 24510868
• Report Number: 3042177665-2026-000004
• Device Sequence Number: 10456685
• Product Code: LNH
• UDI-Device Identifier: 00884838095083
• UDI-Public: 00884838095083
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K043147
• 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
• Report Date (Section B): 03/04/2026

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: SMARTPATH TO DSTREAM FOR XR AND 3.0T
• Device Catalogue Number: 781270
• 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: 02/05/2026
• Initial Report FDA Received Date: 03/04/2026
• 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