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

Model Number	INGENIA 1.5T R5 BASED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
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 injury, a large 2nd degree burn to the left side of the chest can be explained by insufficient distance between body parts, a so-called skin-to-skin burn between her left chest and left upper arm.Contributing factors: 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 thermoregulation of patients who are hypertensive is often impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.The total administered specific energy dose of 4.3 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.The ventilation was on level 3.Level 5 is recommended, it supports the cool down mechanism.
Event or Problem Description
Philips received a report through the medwatch system that a patient suffered a large 2nd degree burn to the left side of the chest during a neck and spine examination.The patient required treatment as a result of this injury sustained.The customer did not report this incident through our regular service channels.

• Brand Name: INGENIA 1.5T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC 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: 20012445
• Report Number: 3003768277-2024-04554
• Device Sequence Number: 7201702
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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 R5 BASED
• Device Catalogue Number: 781341
• 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: 07/26/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 159 KG