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

Model Number	INGENIA ELITION S
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received report that the patient during the mri exam experienced a significant burning sensation just above the knee.The mri tech placed a couple of towels in between the coil and his leg and this helped the patient to be able to complete the exam.The patient reported he had to go to the emergency room because of the pain that he had from his mri.The patient did not respond to the question of how big of an area and his responses was "the size of the coil resting on his leg".The patient reports he now has a buildup of scar tissue under the skin where the burn occurred.A burning sensation in itself is not considered a serious injury, however, the patient reported being treated with oral medication and hospitalization and reports scarring to the site of the burn.Upon review of the additional information, it was reported that the hospital stay and rehab were unrelated to the patient heating incident.However, the patient's scarring is classified as a permanent impairment / damage to the body structure.
Additional Manufacturer Narrative
Philips has started an investigation; a follow up report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
A male patient, (b)96) old, was positioned headfirst supine, for pelvis/prostate exam examination with the anterior coil.The patient reported during the mri exam he experienced a significant burning sensation just above the knee.The mri tech placed a couple of towels in between the coil and his leg and this helped the patient to be able to complete the exam.The patient reported he had to go to the emergency room because of the pain that he had from his mri.The patient did not respond to the question of how big of an area and his responses was "the size of the coil resting on his leg".When the facility manager asked what kind of treatment he received for the burns the patient could only tell them "some pill".The patient reports he now has a buildup of scar tissue under the skin where the burn occurred.A burning sensation in itself is not considered a serious injury however, the patient reported being treated with oral medication and hospitalization and reports scarring to the site of the burn.Patient's scarring is classified as a permanent impairment / damage to the body structure.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.Based on the available information provided, the reported injury most likely occurred due to skin-skin contact between the legs of the patient.No padding was used to prevent this contact and there was potential skin-skin contact during the scan, contributing factors to this incident are as follows: 6 scans with high sar values (>2 w/kg, at 2.4-3.2 w/kg) were executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.The ventilation was on not used according to patient heating questionnaire and it is unknown if it was used according to logfile.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: 22937492
• Report Number: 3003768277-2025-008662
• Device Sequence Number: 9920062
• Product Code: LNH
• UDI-Device Identifier: 00884838098329
• UDI-Public: (01)00884838098329
• 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,Followup
• Report Date (Section B): 10/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: INGENIA ELITION S
• Device Catalogue Number: 782106
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG