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 Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/01/2025
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 suffered a burn/blister on his hand (2cm blister) during lumbar spine scan.During the scan he did not press the nurse call after feeling the sensation in the last sequence.The patient was wearing a hospital gown and underwear and his hands were at his side during the exam.It appears the left hand below the thumb, over joint area there is a circular fluid filled blister.No medical intervention was required and the patient is expected to fully recover.This reported injury meets the criteria for serious injury as this is a blister on the hand.
Event or Problem Description
Philips received a report that shortly after the scan, the patient experienced a burn/blister on his hand (2cm blister).It appears the left hand below the thumb, over joint area there is a circular fluid filled blister.During the scan he did not press the nurse call after feeling the sensation in the last sequence.The patient was wearing a hospital gown and underwear and his hands were at his side during the exam.No medical intervention was required and the patient is expected to fully recover.
Additional Manufacturer Narrative
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 injury, 2nd degree burn at the left hand below the thumb is consistent with heating incidents caused by insufficient distance between body parts, a so-called skin-to-skin burn.It was stated in the patient heating questionnaire, that no padding was used to prevent this contact.The location of the burn is clearly indicating a skin-skin related rf burn, as it appears it most likely occurred due to skin-skin contact between the thumb and the hip/thigh of the patient.Contributing factors to this incident are as follows: 1 scan with high sar values (>2 w/kg; at 2.12 w/kg) was executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.The patient ventilation was used, but it is unknown at what level.Level 5 is recommended for high sar scans, it supports the cool down mechanism.A sheet of blanket covered the patient which hindered the heat dissipation.

• 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: 23376978
• Report Number: 3003768277-2025-013025
• Device Sequence Number: 18367619
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 00884838090040
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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,Followup
• Report Date (Section B): 11/04/2025

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 AMBITION X
• Device Catalogue Number: 781356
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/04/2025
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 65 KG