MAUDE Adverse Event Report: Philips Medical Systems Nederland B.V. Ingenia; Full-body MRI system, superconducting magnet

Model Number	Ingenia Ambition X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Blister (4537); Skin Burning Sensation (4540)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a 69-year-old female patient sustained a second-degree thermal burn with blistering on the upper left arm during an mri examination.During the scan, the patient experienced an intense sensation of heat and activated the nurse call button.Following completion of the examination, a burn injury measuring approximately 1 × 3 cm with blister formation was identified.The reported injury was documented with supporting photographs, a second degree burn with a blister >2.5 cm occurred.The patient was treated with a cool, damp cloth to the affected area.Given the severity of the injury, the presence of a second-degree burn with blistering, and the inability to rule out the potential for permanent impairment, the event meets the criteria for a serious injury.Therefore, this event has been determined to be reportable.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.

• 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 ; 3000 minuteman road; andover, MA 01810 ; +1(978)659-3000
• MDR Report Key: 50766660
• Report Number: 3042177665-2026-000157
• Device Sequence Number: 15817779
• Product Code: LNH
• UDI-Device Identifier: 00884838108622
• UDI-Public: (01)00884838108622
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K18479
• 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): 09/15/2026

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 Ambition X
• Device Catalogue Number: 782138
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 143 LB