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	01/08/2026
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 developed a burn/blister on the right forearm, during cervical and lumbar spine exam.The blister size is reported as 15 cm long.The patient was examined by the nurse and cooling was applied.It is reported, it is unknown if the injury will heal completely.The reported injury 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, second degree burn, most likely occurred as the coil/dstream interface cable was in direct contact with the skin and no padding was used between the cable and the right arm.The coil was inspected after the incident and it was indicated that the cable became hot, due to cable-to-skin contact and no padding used to prevent that contact.In case a distance of 2cm is maintained with padding an injury to the patient is unlikely even if the cable became hot to the touch.Therefore, the injury was determined to be caused by direct cable-to-skin contact as also confirmed by the customer.Contributing factors to this event are as follows: the mr examination room temperature was 22 degrees celsius, which is at the limit as described in the ifu (<22 degrees celsius).The heat dissipation is hindered by a high examination room temperature.A lower examination room temperature reduces the risk on burns, since the patient is less likely to sweat.In this case, it was reported that the patient was sweating.
Event or Problem Description
Philips received a report that the patient developed a burn/blister on the right forearm, during cervical and lumbar spine exam.The blister size is reported as 15 cm long.The patient was examined by the nurse and cooling was applied.It is reported, it is unknown if the injury will heal completely.The reported injury 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: 24275510
• Report Number: 3003768277-2026-100592
• Device Sequence Number: 18623657
• Product Code: LNH
• UDI-Device Identifier: 00884838112841
• UDI-Public: (01)00884838112841
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K223442
• 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): 03/05/2026

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: 782152
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG