MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA; SYSTEM NUCLEAR MAGNETIC IMAGING

Model Number	INGENIA 3.0T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
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 was no indication of a malfunction which would have contributed to the incident.The likely cause was skin-to-skin contact between the patient¿s hand and thigh due to a lack of padding.The injuries skin reddening and two small blisters are consistent with localized heating due to insufficient separation between body parts.This is typically referred to as a skin-to-skin burn.Skin-to-skin contact can form an rf loop and is a known cause for rf heating incidents during an mri scan.To prevent skin-to-skin rf heating incidents, avoid direct and near contact between skin surfaces.You can do this by ensuring there is space between body parts or by placing an insulator between the body parts.To facilitate this insulation, every mr system is delivered with a set of positioning aids, including several spacers and cushions.Contributing factors: check contributing factors file -5 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 mr examination room temperature was above the specified value.The heat dissipation is hindered by a high examination room temperature.A lower examination room temperature reduces the risk on burns, since the patient is less likely to sweat.
Event or Problem Description
Philips received a report that the patient experienced skin reddening and two small blisters (approximately 10 mm each) on the right index finger.The patient was undergoing an abdominal procedure in headfirst, supine position.No medical treatment was administered.The patient was not under sedation.The reported reddened area with two small blisters meets the criteria for a serious injury as the reported burn is on the patient's hand.

• Brand Name: INGENIA
• Common Device Name: SYSTEM NUCLEAR MAGNETIC IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 22326622
• Report Number: 3003768277-2025-005824
• Device Sequence Number: 9582555
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: (01)00884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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 3.0T
• Device Catalogue Number: 781342
• 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: 05/30/2025
• Initial Report FDA Received Date: 06/25/2025
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG