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

Model Number	INGENIA 3.0T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that there was a potential burn in the mri scan room, but they are not sure what caused it.Actual harm has been alleged but there are no details provided to assess the severity of the reported issue.Additional information is required to assess the severity of the reported issue.As there is insufficient information within the event description, we are unable to rule out serious injury and therefore out of precaution, we decided to report this incident.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
A male patient, 73 years old, was positioned headfirst supine, for prostate mri examination with the anterior coil.Patient reported no issues during scan.Four days later patient returned and reported anomaly on inner thigh area.The presence of the skin anomaly was located on his left inner thigh and partially involving his scrotal area.He stated that affected area has since extended downward toward the knee.A digital photo of the affected area is not available.It was reported his physician advised him to go to urgent care.The current status of the patient is unknown.Actual harm has been alleged but there are no details provided to assess the severity of the reported issue.After our investigation and analysis, it was concluded that the mr system and coil used in this case were working correctly.There was no indication of a malfunction which would have contributed to the incident.The reported injury, skin anomaly on the left inner thigh and partially involving his scrotal area of the patient is consistent with heating incidents caused by insufficient distance between body parts, a so-called skin-to-skin burn.It was stated in the patient heating questionnaire, that no padding was used to prevent this contact.The location of the burn is indicating a skin-skin related rf burn, as it appears it most likely occurred due to skin-skin contact between the thighs of the patient.
Event or Problem Description
Philips received a report that four days after the scan patient returned and reported anomaly on inner thigh area.The presence of the skin anomaly was located on his left inner thigh and partially involving his scrotal area.He stated that affected area has since extended downward toward the knee.It was reported his physician advised him to go to urgent care.The current status of the patient is unknown.Actual harm has been alleged but there are no details provided to assess the severity of the reported issue.Additional information is required to assess the severity of the reported issue.As there is insufficient information within the event description, we are unable to rule out serious injury and therefore out of precaution, we decided to report this incident.

• 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: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 23642039
• Report Number: 3003768277-2025-015279
• Device Sequence Number: 13275035
• Product Code: LNH
• UDI-Device Identifier: 00884838098299
• UDI-Public: (01)00884838098299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193215
• 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
• Report Date (Section B): 01/14/2026

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 3.0T
• Device Catalogue Number: 782103
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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 Sex: Unknown