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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient suffered a full thickness burn (i.E.Third degree) and a second degree burn with a blister >2.5 cm on each inner thigh directly across from one another, during pelvis examination, using torso coil.
Additional Manufacturer Narrative
There is no indication of a malfunction of the mr system or coils used that could have contributed to the incident.The injuries, a full thickness burn (i.E.Third degree) and a second-degree burn with a blister >2.5 cm on each inner thigh directly across from one another, are consistent with heating incidents caused by insufficient distance between body parts, a so-called skin-to-skin burn.No padding was used to prevent this from occurring.Skin-to-skin contact can easily occur in the groin area and between the inner thighs.However, near contact in the groin area cannot easily be prevented and it does not always lead to skin-to-skin burns.Whether or not the skin is moist is one of the potentially decisive factors.Moist skin has an increased burn risk as sweat lowers the skin resistance.

• 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: 20236498
• Report Number: 3003768277-2024-05197
• Device Sequence Number: 12950459
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: 09/10/2024
• Initial Report FDA Received Date: 09/17/2024
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 63 KG