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

Model Number	INGENIA 1.5T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient heating form was send today to customer.Actually the event date is unknown, waiting information from customer.Translation of the attached email: good morning, (b)(6), thank you for the confirmation of the software version without any connection, (b)(6) alerted me to the occurrence of two very close cases of burns on the left side of the patient, in the normal direction.1st case of proven burns on the breast, obese patient, push button (shirt) in contact with the mri hood and the breast.Mri in progress it has taken steps to isolate the patient's skin with the mri hood.No antenna elements (flexible antenna) are in contact with the patient.I am asking for your opinion.Can we rule out the hypothesis of heating at the level of a gradient coil? of another component? do you have any internal probes? a monitoring of the temperature or power consumption of a component located at this location? how could we prove the absence/presence of internal heating on mri? your elements should allow us to make the right hypotheses.Thank you for your input, (b)(6).
Event or Problem Description
The patient heating form was send today to customer.Actually the event date is unknown, waiting information from customer.Translation of the attached email: good morning, (b)(6), thank you for the confirmation of the software version without any connection,(b)(6) alerted me to the occurrence of two very close cases of burns on the left side of the patient, in the normal direction.1st case of proven burns on the breast, obese patient, push button (shirt) in contact with the mri hood and the breast.Mri in progress it has taken steps to isolate the patient's skin with the mri hood.No antenna elements (flexible antenna) are in contact with the patient.I am asking for your opinion.Can we rule out the hypothesis of heating at the level of a gradient coil? of another component? do you have any internal probes? a monitoring of the temperature or power consumption of a component located at this location? how could we prove the absence/presence of internal heating on mri? your elements should allow us to make the right hypotheses.Thank you for your input, (b)(6).Biomedical engineer of the (b)(4) nîmes.Material resources department / 06 35 23 32 38.

• Brand Name: INGENIA 1.5T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD.; 281 hillmount road; markham, ontario L6C 2 S3; CA L6C 2S3
• MDR Report Key: 9841492
• Report Number: 3003768277-2020-01003
• Device Sequence Number: 727230
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 884838009820
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• 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
• Distributor Facility Aware Date: 02/27/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Weight: 129