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 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	12/16/2025
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 experienced skin reddening and blistering on the right side of the left thumb.There is a scab reported to be 1 cm x 1 cm.The burn appeared more than one hour after the exam.The patient reported the burn 28 days after the examination.The patient did not undergo medical treatment.The reported injury to the patient's hand meets the criteria for a serious injury.
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 reported injury, skin reddening and blistering on the right side of the left thumb most likely caused by the excessive local sar due to skin-skin contact.From the provided patient heating questionnaire, it was stated by the customer that padding used to prevent skin-skin contact, but customer also indicates skin-skin contact was possible (customer indicates: hand tight contact separated by philips accessories (padding), but patient could have moved his hand during the scan).
Event or Problem Description
Philips received a report that the patient experienced skin reddening and blistering on the right side of the left thumb.There is a scab reported to be 1 cm x 1 cm.The burn appeared more than one hour after the exam.The patient reported the burn 28 days after the examination.The patient did not undergo medical treatment.The reported injury to the patient's hand meets the criteria for a serious injury.

• 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: 24312932
• Report Number: 3003768277-2026-100678
• Device Sequence Number: 5572841
• Product Code: LNH
• UDI-Device Identifier: 00884838099364
• UDI-Public: (01)00884838099364
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 03/04/2026

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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/04/2026
• 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
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 95 KG