MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA AMBITION X

Model Number	INGENIA AMBITION X
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report on a case of a potential misdiagnosis whilst using the ingenia ambition x mr system.
Additional Manufacturer Narrative
The customer was contacted in order for us to analyze the images of the examination in question.However, it was reported to us that the patient did not provide consent for the anonymized images to be provided to philips.Therefore no analysis was possible from our side.The customer however provided additional information on the event.The reported incident was not exactly as originally described in the complaint filed with philips.It was a missed diagnosis not related to a cancerous lesion, but rather a small anomaly that was picked up on a another mr system.Upon reassessment of the philips ambition 1.5t images of the patient, this anomaly was also visible on these images.Therefore the complaint was unfounded.H3 other text : no consent to evaluate the images.

• Brand Name: INGENIA AMBITION X
• Common Device Name: INGENIA AMBITION X
• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15787215
• Report Number: 3003768277-2022-00930
• Device Sequence Number: 12168070
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 884838090040
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K18479
• 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
• Type of Report: Initial,Followup

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
• Device Model Number: INGENIA AMBITION X
• Device Catalogue Number: 781356
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 03/21/2023
• 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 Sex: Unknown