MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T

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	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips has started an investigation.A follow up will be send when the investigation has been completed.
Event or Problem Description
Philips received a report that a patient suffered a large 2nd degree burn on the right elbow after an mr examination that was performed while the patient was under anesthesia.
Additional Manufacturer Narrative
Conclusion: there is no indication of a malfunction of the mr system or coils used that could have contributed to the incident.The observed reddening and blister can be explained by close contact with the bore wall.Even though it was mentioned that padding was used, taking into consideration the patient's size and the duration of the examination it is likely that the padding used was insufficient and/or that the padding moved during the examination.This reported burn is considered a second degree burn and was determined to be a serious injury.Treatment to right arm blister was to clean the area and pat dry and betadine solution was used.No further medical treatment was required.Contributing factors.The patient was obese.The thermoregulation of obese patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.The patient was anesthetized.The thermoregulation of anesthetized patients is impacted.The circulation of the limbs is lower than normal.So, the heat dissipation of the limbs is less due to the anesthesia.3 scans with high sar values (> 2 w/kg) were executed in a short period of time, allowing no cool down time for the patient.The total administered specific energy dose of 6.38 kj/kg exceeded the recommended limit of 2.0 kj/kg for patients with impaired thermoregulation.

• Brand Name: INGENIA 3.0T
• Common Device Name: INGENIA 3.0T
• 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: 16990276
• Report Number: 3003768277-2023-03122
• Device Sequence Number: 17923628
• Product Code: LNH
• UDI-Device Identifier: 00884838009813
• UDI-Public: 884838009813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: 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 3.0T
• Device Catalogue Number: 781377
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/18/2023
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 129 KG