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

Model Number	INGENIA ELITION X
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has started an investigation, a follow up will be provided once completed.
Event or Problem Description
Philips received a report that allegedly a misdiagnosis had occurred due to an image quality issue.During a post contrast study a malignant process did not show up enhancing enough as anticipated which lead to a wrong diagnosis.This could lead to that the diagnosis and treatment has to be altered with potential long term effects.
Additional Manufacturer Narrative
Problem reported issue: unexpected enhancement pattern seen in sarcoma patients.Occurrence is low.The un-expected enhancement pattern has resulted in a misdiagnosis.Customer has indicated they suspect image scaling to be the issue and has shared dicom data.All dicom data that has been provided by the customer has been reviewed with several experts, reconstruction, image domain and clinical experts to check on technical problems.Technical assessment on all the clinical cases shared: image scaling is ruled out ¿ histograms on the images show that all pixel values are displayed, no signal clipping occurred.Mdixon water fat swop ¿ notice on the thorax wall dataset but only at the area of the oil capsules that were positioned outside the body.Root cause was identified as phase difference due to local field disturbance (susceptibility).Transmit/receive problem is ruled out, as this would not manifest following anatomical boarders.Our conclusion is that there is no system problem.The fact that a different enhancement pattern is seen is not due to a system failure.

• Brand Name: INGENIA ELITION 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: 19180042
• Report Number: 3003768277-2024-02443
• Device Sequence Number: 20683435
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: 884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173356
• 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
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INGENIA ELITION X
• Device Catalogue Number: 781358
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/03/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG