MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA AMBITION X; SYSTEM NUCLEAR MAGNETIC 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	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of a coil or system malfunction that could have contributed to the injury.The patient subsequently stated that there was increased heat development in the left hand area at the end of the examination.The injuries, 2nd degree burns on the patient's left hand a 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.There may have been direct contact between the patient's hand and the thigh/buttocks.Considering the possible direct contact between the patient's hand and the thigh/buttocks, the burns can be explained by skin-to-skin contact, which allowed an rf loop to form.
Event or Problem Description
Philips received a report that a male patient suffered 2nd degree burns on his left hand after lumbar spine examination with the contrast agent.

• Brand Name: INGENIA AMBITION X
• 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: 19700577
• Report Number: 3003768277-2024-03725
• Device Sequence Number: 7719946
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 884838090040
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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 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: 07/03/2024
• Initial Report FDA Received Date: 07/09/2024
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 87 KG