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

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	02/06/2025
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 a heating sensation, skin reddening, and blistering during left axillary softness tissue examination.The burn was reported as a 2nd degree 10 cm sized area on the right lateral upper arm area.Three digital photos were received for review.In one, there is an area which shows the reported blistering in multiple areas and erythema.The other two photos show the wound in various stages of healing.It is reported the injury is expected to scar.It was reported there was no medical intervention performed.
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 patient was positioned headfirst, supine, off-center with the right arm closer to the bore.The rf burn occurred at the right upper arm.A skin to bore contact was identified as most reasonable scenario for the rf burn.In addition to the above, 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: 21665576
• Report Number: 3003768277-2025-002700
• Device Sequence Number: 15369120
• Product Code: LNH
• UDI-Device Identifier: 00884838112841
• UDI-Public: (01)00884838112841
• 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,Followup
• Report Date (Section B): 04/01/2025

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: 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: 02/21/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/01/2025
• 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
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 82 KG