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 Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.
Event or Problem Description
Philips received a report that after the mri examination was completed and the bed was pulled out, sleeping patient woke up and raised his head while the in-bore mirror was still attached, causing contact with the mirror and injuring his right eye.The patient was seen by a provider in the facility and was prescribed eye drops to treat conjunctival hemorrhage in the right eye.Eye drops prescribed by a physician meet the criteria for medical intervention to preclude permanent impairment.The patient was later observed at ophthalmology department.It was reported, the patient did not have vision abnormalities.The patient condition is currently under observation after being examined by an ophthalmologist.The reported injury meets the criteria for a serious injury.
Additional Manufacturer Narrative
The patient was an 82-year-old male individual who had a history of dementia.During the scan the patient fell asleep; after the scan was completed, the operator manually moved the table fully out of the bore, which awakened the patient.The patient abruptly sat up while the in-bore mirror (which is reflective plastic part and designed with contoured and rounded edges, reducing the potential for sharp contact) remained attached and struck the lower edge of the mirror assembly with the right eye; the mirror remained intact and did not shift or detach.The operator had instructed the patient not to move; however, the sudden awakening led to the unexpected sit-up.The reported injury was a conjunctival hemorrhage confined within the eye.Immediately after the event, the patient was evaluated by a neurosurgeon; no treatment or hospitalization was required at that time.Subsequently (exact day not specified), the patient visited their regular ophthalmologist as an outpatient and was treated with eye drops and was not hospitalized; the specific medication (type of eye drop) is unknown.At a one-week follow-up call, the patient reported improvement and no current issues; no vision problems were reported.Based on the available information, the reported event meets criteria for serious injury.A site service review of the in bore mirror¿s appearance and installation found no issues.After our investigation and analysis, it was concluded that the mr system and coil where the mirror as attached to used in this case were working correctly.There is no indication of a malfunction of the mr system or coil used that could have contributed to the incident.The injury occurred following a non intended sequence of use during the mri examination.The patient, who had advanced age and an underlying medical condition (dementia), fell asleep during the scan.As confirmed by the field service engineer (fse), the patient was awakened by table movement, assumed that the examination had concluded, and abruptly attempted to sit up while the mirror assembly was still installed.This type of spontaneous and uncontrolled patient action is not anticipated in normal use conditions nor is it reasonably foreseeable.

• 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: luis casillas lc ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 24255730
• Report Number: 3003768277-2026-100543
• Device Sequence Number: 12862742
• Product Code: LNH
• UDI-Device Identifier: 00884838098336
• UDI-Public: (01)00884838098336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193215
• 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,Followup
• Report Date (Section B): 04/14/2026

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: 782107
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male