MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MR 7000 SERIES; 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 Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	02/10/2025
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 sustained a burn to the left inner forearm, reported as a 2nd degree burn approximately 6 cm in size.Blistering and a heating sensation were reported during a breast mri.Medical treatment provided to the wound was biafine.The digital photo provided shows the left forearm with the reported would, circular in shape with a white center.The burn appears to be through the dermis layer of the patient's skin.
Additional Manufacturer Narrative
The photograph received appears to note a third degree burn.The image shows the left forearm with the reported wound, circular in shape with a white center.The burn appears to be through the dermis layer of the patient's skin.The reported injury of a third degree burn, 6 cm in size, meets the criteria for a serious injury.Based on the investigation preformed and analysis done, it was concluded that the mr system and coil used in this case were working correctly.There is no indication of a malfunction which would have contributed to the incident.During the examination, the patient came into contact with the cable, which could have led to the induction of radiofrequency (rf) currents on the patient body causing burns.It was reported that the cable became hot to the touch.The incident happened because the operator failed to leave sufficient space between cable and patient body as instructed in instruction for use (ifu).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.It was found that the operator missed to place the system cable cover (dedicated sleeve) during the patient examination.This was the only exam where the sleeve was not installed on the coil cable.It was installed after the event, and no issues have been reported since.The product is conforming to its intended use and applicable regulations; the issue is attributed to use error due to lack of strict adherence to instructions and warnings given in ifu, refer attached ¿300009184272_ifu_7700_int_pnl_ce_en-us.Pdf¿.The padding (system cable cover) was not used to avoid direct contact between the left forearm and the coil cable.

• Brand Name: MR 7000 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: 21640834
• Report Number: 3003768277-2025-002636
• Device Sequence Number: 8510011
• Product Code: LNH
• UDI-Device Identifier: 00884838104112
• UDI-Public: (01)00884838104112
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K213516
• 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): 10/21/2025

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 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: 02/24/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 10/21/2025
• 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; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 74 KG