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

Model Number	INGENIA ELITION X
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Itching Sensation (1943); Partial thickness (Second Degree) Burn (2694); Insufficient Information (4580)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient underwent a right shoulder mri scan.The patient did not press the nurse call button during the procedure.The anatomic details of the patient view were not provided.The patient was positioned supine with their right arm externally rotated, roll under their arm padding and hand rails pushed in, to keep arm in place.It is reported the coil used for the exam was the ds shoulder 16 ch 3.0t.There were no specific details provided about what the actual shoulder burn/injury is.There were also no details provided on medical intervention given to the patient.Due to insufficient information in this case, the serious injury cannot be ruled out.Therefore, we have decide to report this event out of an abundance of caution.
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 underwent a right shoulder mri scan.The patient did not press the nurse call button during the procedure.The patient was positioned supine with their right arm externally rotated, roll under their arm padding and hand rails pushed in, to keep arm in place.It is reported the coil used for the exam was the ds shoulder 16 ch 3.0t.Patient experienced burn after shoulder exam.The blistering was noted, approximately 3cm oblong scabbed area on the patient's right upper back to the left of a tattoo.The fluid in the blister is not present.The edges are irregular shaped, and the wound appears to be through the initial epidermal layer.No medical intervention was provided.Due to the size of the reported blister, the reported injury meets the criteria for a serious injury.
Event or Problem Description
Philips received a report that the patient underwent a right shoulder mri scan.The patient did not press the nurse call button during the procedure.The patient was positioned supine with their right arm externally rotated, roll under their arm padding and hand rails pushed in, to keep arm in place.It is reported the coil used for the exam was the ds shoulder 16 ch 3.0t.Patient experienced burn after shoulder exam.The blistering was noted, approximately 3cm oblong scabbed area on the patient's right upper back to the left of a tattoo.The fluid in the blister is not present.The edges are irregular shaped, and the wound appears to be through the initial epidermal layer.No medical intervention was provided.Due to the size of the reported blister, the reported injury meets the criteria for a serious injury.
Additional Manufacturer Narrative
A female patient, 59 years old, was positioned head first, supine, for the right shoulder examination with the ds shoulder 16ch 3.0t coil.The patient was positioned supine with her shoulder being placed on the dedicated shoulder coil.The patient wore hospital supplied clothing which was reported to day and made up 100 % cotton or linen.It was reported that the patient experienced reported burn after shoulder exam.The blistering was noted, approximately 3cm oblong scabbed area on the patient's right upper back to the left of a tattoo.The fluid in the blister is not present.The edges are irregular shaped, and the wound appears to be through the initial epidermal layer.No medical intervention was provided.Due to the size of the reported blister, the reported injury meets the criteria for a serious injury.After our investigation and analysis, it was concluded that the mr system and coils used in this case were working correctly.There is no indication of a malfunction of the mr system or coils used that could have contributed to the incident.The patient experienced burn after shoulder exam.The blistering was noted, approximately 3cm oblong scabbed area on the patient's right upper back to the left of a tattoo.That most likely, the thermal load exceeded the capacity of the patient.In other words, the patient environment caused thermal load and limited the patient's ability to lose heat.This can happen when for example the patient is in contact with a non permeable surface (e.G., coil, mattress or padding), when there is insufficient airflow in the bore, e.G., due to the airflow set too low (as was the case according to the patient heating questionnaire, the patient ventilation wat set to level 3 instead of level 5) in combination with high sar scans with the little time in between to allow the patient to cool down.These are all variables that could have resulted in the issue as described and resulting injury.Contributing factors in this case are as follows: 8 scans with high sar values (>2 w/kg) were executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.The ventilation was on level 3.Level 5 is recommended for high sar scans, it supports the cool down mechanism.

• Brand Name: INGENIA
• 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: 24740635
• Report Number: 3042177665-2026-000019
• Device Sequence Number: 15770535
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: 00884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2026

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: INGENIA ELITION X
• Device Catalogue Number: 781358
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 05/26/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/18/2026; 06/19/2026
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 121 LB