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

Model Number	INGENIA AMBITION X
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a medwatch report (mw5115933) about an incident where an 11 year old girl had sustained a large (3cm) 2nd degree burn on the right calf of her leg during a double mr examination that was performed under general anesthesia.
Additional Manufacturer Narrative
Philips requested and received additional information from the reporter.She stated that the patient was positioned in such a way that the left heel was touching the right calf; the left leg was in a "fixed" frog leg position.Padding was used initially to keep the legs from touching, however, the left heel slid up against the right calf after scooting the patient up to get her into a better position.As the patient was under general anesthesia, she was not able to inform the users of any burning sensation that could have prevented the burn level from increasing.The user reported that there were no other issues with the equipment or external materials used.They have added an additional safety step to double check contact positioning prior to scanning.Conclusion: this burn was the result of an rf loop resulting from skin to skin contact.H3 other text : cause already identified by user.

• Brand Name: INGENIA AMBITION X
• Common Device Name: 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: 17115737
• Report Number: 3003768277-2023-03560
• Device Sequence Number: 15242347
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 884838090040
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K181479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 AMBITION X
• Device Catalogue Number: 781356
• 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: 03/28/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 11 YR
• Patient Sex: Female
• Patient Weight: 38 KG