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

Model Number	INGENIA ELITION S
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report about an attraction incident on an elition mri in which a hospital employee was injured.
Additional Manufacturer Narrative
No functional tests were performed as this issue was caused by a use error by bringing a non-mr safe bed 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 an injury occurred.

• Brand Name: INGENIA ELITION S
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 21968054
• Report Number: 3003768277-2025-004123
• Device Sequence Number: 18261611
• Product Code: LNH
• UDI-Device Identifier: 00884838088108
• UDI-Public: 00884838088108
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• 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): 05/06/2025

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 S
• Device Catalogue Number: 781357
• 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: 04/12/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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