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

Model Number	INGENIA 1.5T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient experienced a blister on a left index finger shortly after the examination.A male patient, 40 years old, was positioned feet first, spine, for pelvis and lumbar spine examination with the anterior array coil.It was reported the patient was sedated or anesthetized for the scan.No medical treatment was provided.A digital photo of the wound was provided and is described as an oval shaped blister on the lateral side of the index finger at the area/level of the nail bed.The skin is intact.The blister area is whiteish in color and is surrounded by an area of erythema.The size of the blister is approximately 2.5-3cm.The reported blister on the finger meets the criteria for a serious injury.
Additional Manufacturer Narrative
There is no indication of an mr system or coil malfunction identified which could have contributed to the incident.It was confirmed that a pulse oximeter was present during the mr exam on the patient's left index finger where the reported burn/blister is located.Considering the place, shape and nature of the burn injury, and by ruling out all other potential causes for this burn, the burn could have resulted from the pulse oximeter's tight clamping or pinching on the patient's finger.In that scenario blood flow is also somewhat restricted which could lead to a hampering of proper heat dissipation, leading to the heating incident.The pulse oximeter is indicated to be mr conditional equipment (i.E., not mr safe), meaning that this pulse oximeter is safe to use in the mr environment only under specified conditions (e.G., field strength, spatial gradient, sar limits, coil type, orientation).Contributing factors for this events are as follows: the patient was sedated or anesthetized.The thermoregulation of sedated patients is known to be impaired.The patient was unable to sense or communicate discomfort or pain.

• 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: 25158009
• Report Number: 3042177665-2026-000068
• Device Sequence Number: 21218211
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: (01)00884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163116
• 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): 05/13/2026

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 1.5T
• Device Catalogue Number: 781341
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/13/2026
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 66 KG