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

Model Number	INGENIA ELITION X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient underwent a right shoulder mri scan.The patient did not press the nurse call button during the procedure.The anatomic details of the patient view were not provided.The patient was positioned supine with their right arm externally rotated, roll under their arm padding and hand rails pushed in, to keep arm in place.It is reported the coil used for the exam was the ds shoulder 16 ch 3.0t.There were no specific details provided about what the actual shoulder burn/injury is.There were also no details provided on medical intervention given to the patient.Due to insufficient information in this case, the serious injury cannot be ruled out.Therefore, we have decide to report this event out of an abundance of caution.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.

• Brand Name: INGENIA ELITION X
• 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: 24740635
• Report Number: 3042177665-2026-000019
• Device Sequence Number: 17218454
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: (01)00884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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 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: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 55 KG