MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 1.5T; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	INGENIA 1.5T R5 BASED
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient suffered a burn in his thumbs during a lumbar examination.The reported burn is reported as skin reddening and blistering on the left thumb, second degree approximately 2 cm blister size.The appearance of the burn onset was less than one hour after the examination.First aid was administered; a dressing was put over the wound.It is expected that the patient will fully recover.
Additional Manufacturer Narrative
After our investigation and analysis, it was concluded that the mr system used in this case was working correctly.There is no indication of a malfunction of the mr system used that could have contributed to the incidents.The injury, rf burn reported as a skin reddening (first degree) and blistering on the left thumb (second degree) approximately 2 cm blister size, is consistent with heating incidents caused by insufficient distance between body parts, a so-called skin-to-skin burn.No padding was used to prevent this from occurring and there was a potential skin-to-skin contact.The body parts were separated only by the clinical cloth.It is reported the client is using new medical cloth for two weeks, and that the new cloth is thinner than the old one.Contributing factors to this incident are as follows: the patient was reported to have passive implants, unable to sense or communicate heat sensation, is obese and has an impaired ability to perspire.The thermoregulation of those patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.3 scans with high sar values (>2 w/kg, at 2.44 w/kg) were executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.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 1.5T
• 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: 22684398
• Report Number: 3003768277-2025-007051
• Device Sequence Number: 9000236
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: (01)00884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K163116
• 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): 08/01/2025

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 1.5T R5 BASED
• Device Catalogue Number: 781341
• 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: 07/03/2025
• Initial Report FDA Received Date: 08/01/2025
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 96 KG