MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MR 7700; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	MR 7700
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/10/2026
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 felt a heating sensation and experienced skin reddening and blistering on the right upper shoulder clavicle area; a 4x4cm circular burn overlying right coracoid process.Burn consists of 2x2cm central component with surrounding area of erythema.Sensation is intact in area involving the burn and it is not particularly tender to touch, the affected size of the blister is reported to be 4 cm.Medical treatment by the ward doctor and plastic surgeon was given.The reported injury meets the criteria for a serious injury.
Additional Manufacturer Narrative
After our investigation and analysis, it was concluded that no contribution was identified from the associated mr coils (head and base coil) or the mr system used during the scan with respect to the reported harm.The associated mr coils (head and base coil) cannot reach the affected body area.The incident is attributed to the use of high specific absorption rate (sar) sequences performed consecutively without adequate breaks, leading to excessive accumulation of rf energy and localized tissue heating.Other potential causes such as cable contact, skin-to-skin contact, clothing-related effects, implants, or contact with the bore are considered unlikely based on the available information.

• Brand Name: MR 7700
• 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: 24275511
• Report Number: 3003768277-2026-100591
• Device Sequence Number: 15934497
• Product Code: LNH
• UDI-Device Identifier: 00884838104112
• UDI-Public: (01)00884838104112
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/27/2026

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 7700
• Device Catalogue Number: 782120
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 22 YR
• Patient Sex: Male
• Patient Weight: 88 KG