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

Model Number INGENIA 1.5T

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

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

Event Date 03/10/2023

Event Type  Injury  

Event Description

Philips received a report that a patient suffered a large 2nd degree burn on her thigh after a spinal examination.

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.

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
• Type of Device: 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
• MDR Text Key: 315920310
• Report Number: 3003768277-2023-03299
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 884838009820
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K110151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/17/2023
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 160 KG