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 Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient experienced the burn, while undergoing a brain and spine/neck mri scan with contrast.The exam was a long duration approximately 90 minutes with the patient sedated.Per the diagram on the heating questionnaire, the patient 's right forearm and area had an area of blistering.The burn depth or degree is reported as "1".The burn emerged shortly after the exam.It is unknown if the burn will heal completely.Local topical treatment was performed, this was not specified.A digital photo was received for review.The patient's right arm is shown with a large area of raised linear shaped swelling which appear to be a developing blister.The area extends from the patient's elbow down past the forearm.The skin appears intact at the time the photo was taken.The size of the blister meets the criteria for a serious injury.Based on the available information, this issue has been determined to be a reportable event.
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 is no indication of a malfunction of the mr system or coil used that could have contributed to the incident.The coils used for the scan were the msk m and ds head coils.The technician reported that coil msk m was not hot.A digital photo was received for review.The patient's right arm is shown with a large area of raised linear shaped swelling which appear to be a developing blister.The area extends from the patient's elbow down past the forearm and appears to match the shape of the coil cable.Therefore, it was concluded, that the burn most likely occurred due to wrong position of patient or coils.The coil cable was in direct contact with the patients arm, no padding was used to prevent this contact.Contributing factors in this case are as follows: the patient's condition, obese and suffering from diabetes, is considered to be a contributing factor.The thermoregulation of such patients is known to be impaired.The patient was sedated.The thermoregulation of sedated patients is known to be impaired.The patient was unable to sense or communicate discomfort or pain.The total administered specific energy dose of 2.71 kj/kg exceeded the recommended limit of 2.0 kj/kg for patients with impaired thermoregulation.

• 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: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 24764970
• Report Number: 3042177665-2026-000030
• Device Sequence Number: 10276613
• 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): 04/02/2026

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: 03/06/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 110 KG