MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MR 5000 SERIES; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	MR 5300
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient experienced burn, blistering on the upper right arm during a shoulder scan.The patient underwent the exam in the head first supine.The patient pressed the nurse call button during the exam to report a heating sensation in the area of the upper right arm.The patient was positioned off-center.The patient wore their own clothing which was reported to be dry, made up of microfibers.It is reported the coil used for the exam was the msk m and msk s coils.The area on the upper right arm is shown oblong in shape and appears to have several blisters inside a reddened area.The largest blister is approximately 3 cm.The reported injury meets the criteria for a serious injury due to the blister size and reported medical treatment provided by the dermatologist.
Additional Manufacturer Narrative
A male patient, 52 years old, was positioned head first, supine, for the right shoulder examination with the msk m and msk s coils.It was reported that the patient experienced a second degree burn shortly after the scan.The patient wore their own clothing which was reported to be dry, made up of microfibers.The patient pressed the nurse call button during the exam to report a heating sensation in the area of the upper right arm.Patient had redness and blistering in this area.It is expected that the burn will heal completely.It was reported the patient was treated by a dermatologist and prescribed topical creams for the burns.The area of the blister was 10 cm x3 cm.Due to the approximate size of the blister in the digital photo, the reported injury meets the criteria for serious injury.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 burn and blister on the upper right arm during a shoulder scan procedure were most likely the result of improper patient or coil positioning, which can lead to unintended rf coupling through the patient and subsequently cause harm.As per information from patient heating questionnaire, it further notes that the coil and/or coil cable was positioned close to the affected area, less than 1cm.Patient moved his arm over cable of msk m coil during the study and was touching the bore.Based on the location and elongated shape of the blister, the injury is consistent with a burn caused by direct contact with the cable.This outcome was possible because appropriate padding was not applied to prevent such contact.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.The patient was covered with synthetic fiber blankets.Synthetic fiber is often hindering the heat dissipation as it traps body heat.

• Brand Name: MR 5000 SERIES
• 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: luis casillas lc ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 25701905
• Report Number: 3042177665-2026-000104
• Device Sequence Number: 9453043
• Product Code: LNH
• UDI-Device Identifier: 00884838099364
• UDI-Public: (01)00884838099364
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 07/03/2026

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: 06/09/2026
• Initial Report FDA Received Date: 07/03/2026
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 115 KG