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

Model Number	INGENIA ELITION X
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that during the use of the device, metal was attracted from the outside, resulting in injuries of the hospital staff.Field service engineer has arrived at the venue and together removed the injured person through simple treatment.The injured person received the treatment at the hospital on (b)(6) 2025.The skin and muscles on the right lower leg were injured and bleeding, the extend of which could not be confirmed.There is no more detailed information about the reported event of the harmed user.Based on information available at the time of this report submission, there is insufficient information to determine whether the reported harm meets criteria for serious injury.Therefore, we report this incident out of caution.
Additional Manufacturer Narrative
No functional tests were performed as this issue was caused by a use error by bringing a metal object into the examination room.Based on the provided information there is no indication of a malfunction of the mri system.It is a known issue that no magnetic materials should be brought into the examination room.Based on the information available, the cause of the reported problem was a user error.No information was made available related to the outcome for the user other then that the skin and muscles on the right lower leg were injured and bleeding and that the user received the treatment at the hospital.

• 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: 22236702
• Report Number: 3003768277-2025-005633
• Device Sequence Number: 8019386
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: (01)00884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173356
• 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): 06/17/2025

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 ELITION X
• Device Catalogue Number: 781358
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/17/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown