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

Model Number INGENIA 3.0T

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Philips has started an investigation.A follow up will be send when the investigation has been completed.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315818561
• Report Number: 3003768277-2023-03122
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838009813
• UDI-Public: 884838009813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 129 KG