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	Full thickness (Third Degree) Burn (2696)
Date of Event	05/19/2025
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 the patient sustained an approximate 21 cm burn (third degree) to her left hip area during a lumbar exam in the headfirst supine position.The burn is described as irregular circular shaped open area wound with areas that appear to be burned through several layers of skin.The patient has a history of diabetes, obesity, hypertension and is on anticoagulant therapy.The patient is reported to be undergoing treatment of the burn.
Additional Manufacturer Narrative
A female patient was positioned head first supine, for lumbar examination with the ds posterior coil.Shortly after the examination, the patient sustained an approximate 21 cm burn to her left hip area.The patient experienced a heating sensation during the scan, but she did not press the nurse call.A digital photo of the reported injury was provided for review and matches the reported description.The burn is described as irregular circular shaped open area wound with areas that appear to be burned through several layers of skin.Additionally, information was received that the patient was operated due to complication after the heating incident.The treatment was performed at another hospital and there is no additional information available.After our investigation and analysis, it was concluded that the mr system and coil 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 patient heating incident, (3rd degree) burn 21cm long to the left hip area, is consistent with heating incidents most likely caused by insufficient distance between body parts and bore, referred to as skin-bore rf-burn.The location of the harm in relation to the body coil (close to the ring section) and the shape appearance of the burn (no signs of skin-skin contact or imprint of conducting foreign materials e.G.Metal) are aligned with the most likely cause, skin-to-bore contact.No padding was used to prevent the contact between the skin and the bore wall and the distance to the bore was 0 cm during full scanning, based on the information form patient heating questionnaire.The observed rf burn can be explained by close contact with the bore wall (obese patients touching or in close proximity to body coil), in combination with first level controlled mode.Contributing factors to this incident are as follows: the patient's condition, obese, hypertensive, suffering from diabetes and using anticoagulant therapy, is considered to be a contributing factor.The thermoregulation of those patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.Two scans with high sar values (>2 w/kg, at 2.336 w/kg) were executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.The total administered specific energy dose of 2.86 kj/kg exceeded the recommended limit of 2.0 kj/kg for patients with impaired thermoregulation.The patient ventilation was not at the highest level.Level 5 is recommended for high sar scans; it supports the cool down mechanism.

• 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: 22292180
• Report Number: 3003768277-2025-005684
• Device Sequence Number: 15685836
• Product Code: LNH
• UDI-Device Identifier: 00884838098336
• UDI-Public: (01)00884838098336
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/30/2025

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 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 137 KG