MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T

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	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a patient sustained a 2nd degree burn with skin damage after a lumbar spin examination.
Additional Manufacturer Narrative
Conclusion.Based on the available information, there is no indication of a malfunction of the mr system or coil used that could have contributed to the incident.The observed reddening and skin damage can be explained by close or direct contact between the patient and the bore wall.No padding was used to prevent this.Contributing factors: the thermoregulation of obese and hypertensive patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.Several scans with high sar values (>2 w/kg) were executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.The total administered specific energy dose of 3.7 kj/kg is very high for a patient with impaired thermoregulation.The instructions for use advises to avoid sed >3.0 kj/kg, preferably keep sed <2.0 kj/kg for those patients.

• Brand Name: INGENIA 1.5T
• Common Device Name: INGENIA 1.5T
• 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: 16193690
• Report Number: 3003768277-2023-00340
• Device Sequence Number: 17214775
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 884838009820
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/28/2023
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 162 KG