MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MR 5300; SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	MR 5300
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient suffered a burn with a blister measuring 5 cm to the left leg in the area of the knee during an exam.The patient pressed the nurse call light for a heating sensation during the exam, was given a dermatology referral, and is expected to fully recover.It is unknown what medical treatment was provided by dermatology.Complaint details indicate a second degree burn with a blister >2.5 cm occurred as assessed from the pictures provided.
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.Although it is mentioned that the cable was not in contact with the skin, from the provide photo, the shape of the burns on the leg resemble the shape and form of cabling.Even though it is mentioned that padding was used to keep the cable away from the patient, considering the location and the shape of the burns, we conclude that the most likely scenario is that the padding used must have been mispositioned or otherwise moved during the examination.Contributing factors to this event are as follows: the patient was obese.The thermoregulation of obese patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.

• Brand Name: MR 5300
• Common Device Name: SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: 21147368
• Report Number: 3003768277-2025-000299
• Device Sequence Number: 15736856
• Product Code: LNH
• UDI-Device Identifier: 00884838099364
• UDI-Public: (01)00884838099364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K223458
• 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): 01/14/2025

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: MR 5300
• Device Catalogue Number: 782110
• 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: 01/10/2025
• Initial Report FDA Received Date: 01/14/2025
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 104 KG