MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 1.5T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a patient suffered a large 2nd degree burn on her thigh after a spinal examination.
Additional Manufacturer Narrative
Philips has started an investigation.A follow up will be send when completed h3 other text : incident occurred > 2 months ago, system has been in use since without issues.
Additional Manufacturer Narrative
Conclusion: based on the available information, there is no indication of a malfunction of the mr system or used inbuilt posterior coil that could have contributed to the incident.The observed reddening and blistering on the images provided can be explained by direct contact between the patient and the bore wall.Even though it was mentioned that soft padding was used to prevent bore contact, considering the patients size and duration of the examination (half hour) it is highly likely that either there was insufficient padding or that the padding was moved.The reported burn is considered a second degree burn and was determined to be a serious injury.Contributing factors: the patient was obese, suffered from diabetes and had a fever.The thermoregulation of obese and diabetic patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.The total administered specific energy dose of 2.3 kj/kg is high for a patient with impaired thermoregulation.The instructions for use advises to preferably keep sed <2.0 kj/kg for those patients.

• Brand Name: INGENIA 1.5T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE 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 ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 17001754
• Report Number: 3003768277-2023-03299
• Device Sequence Number: 6579938
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 884838009820
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K110151
• 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,Followup

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: 781396
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 160 KG