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 Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
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 the patient experienced a heating sensation, skin reddening and blistering was noted on the right shoulder area.The burn was described as a surface burn and the size was determined to be minor.The patient was sent to the onsite clinic for evaluation and it is unknown if medical treatment was performed.No follow-up was required.The reported blister is new information per the completed patient heating questionnaire.The size is not documented.Therefore, a serious injury can not be ruled out with the current information provided.
Event or Problem Description
Philips received a report that the patient experienced a heating sensation, skin reddening and blistering was noted on the right shoulder area.The blister area is described as top of right shoulder and shoulder blade/scapula area.Size approximately 0.5-1 in.Minor with redness and potential blister.Customer questioned but unknown regarding blister.The patient was sent to onsite clinic and sent home.No follow-up required.The burn is expected to heal.The injury reported meets the criteria for a non-serious minor injury.
Additional Manufacturer Narrative
A female patient, 68 years old, was positioned head first supine, for right shoulder examination with the shoulder coil.During the examination heating sensation and a reddening with potential blister was observed on the top of right shoulder and shoulder blade/scapula area.Size approximately 0.5-1 in.Customer questioned but unknown regarding blister.The patient was sent to onsite clinic and sent home.The burn is expected to heal.Based on additional information received and re-assessment performed, the reported injury meets the criteria for a non-serious minor injury.After our investigation and analysis, it was concluded that the mr system and coil used in this case were working correctly.There was no indication of a malfunction which would have contributed to the incident.The reported injury, heating sensation and a reddening with potential blister on the right shoulder were most likely caused by a thermal load exceeding the capacity of the patient.Contributing factors to this incident are as follows: 6 scans with high sar values (>2 w/kg, at 2.72-3.20 w/kg) were executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.In addition to this, customer is not applying the sufficient breaks in between exams.The total administered specific energy dose of 3.92 kj/kg exceeded the recommended limit of 3.5 kj/kg.Polypropylene clothing made of synthetic fibers which traps heat.

• 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: 23400852
• Report Number: 3003768277-2025-013238
• Device Sequence Number: 9969971
• Product Code: LNH
• UDI-Device Identifier: 00884838098336
• UDI-Public: (01)00884838098336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: 10/02/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 65 KG