MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA AMBITION X; SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA AMBITION X
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that following the lumbar scan, the patient complained of a blister on the right hand thumb.A 2 cm homogenous blister was present on the right thumb, for which no medical treatment was provided, and the blister was expected to heal.
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 injury, 3rd degree burn with a blister of 2 cm on the right hand thumb appears to be is consistent with heating incidents caused by insufficient distance between body parts, a so-called skin-to-skin burn.Even though it was mentioned that padding was used to prevent this from occurring, no information was provided on the exact location where this padding was positioned.Considering the location of the burn, skin-to-skin contact is the most logical explanation.The patient was elderly, a condition known to affect the body¿s ability to regulate temperature, increasing the risk of rf energy-related injuries.Also, the patient had extensive, dark tattoos, including permanent makeup tattoos on the arms, legs, and chest.During the scan, 3 sequences with high sar values (above 2 w/kg, reaching 2.47 w/kg) was performed, allowing no cool down time for the patient.The total specific energy dose administered was 3.14 kj/kg, exceeding the recommended limit of 2.0 kj/kg for patients with impaired thermoregulation.

• Brand Name: INGENIA AMBITION X
• Common Device Name: SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: 21705598
• Report Number: 3003768277-2025-002827
• Device Sequence Number: 17313977
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: (01)00884838090040
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181479
• 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
• Report Date (Section B): 03/27/2025

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: INGENIA AMBITION X
• Device Catalogue Number: 781356
• 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: 03/10/2025
• Initial Report FDA Received Date: 03/27/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 91 KG