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

Model Number	INGENIA AMBITION X
Medical Device Problem Codes	Compatibility Problem (2960); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has started an investigation, a follow up will be submitted once more information becomes available.
Event or Problem Description
Philips received a report that after a recent software update the image quality of the b1000 appears much brighter than before.Customer is worried that this could lead to misinterpretation/misdiagnosis if this is not recognized.
Additional Manufacturer Narrative
The reported issue was investigated by using dicom and logfile data made available by the customer.It was determined that the cause of the issue was related to the interpretation of the dicom99 export by the pacs vendor.In the software version present on this system, r11.1.01, the dicom99 export the voi lut function(0028,1056) is set to linear_exact by cp for images with a window width greater than 1, causing issues in pacs as linear_exact is interpreted incorrectly by pacs for dicom99 images.The issue has been resolved by implementing the following solution in a software service pack upgrade: voi lut function(0028,1056) = linear_exact is not applicable for dicom99 images.Hence for dicom99 remove voi lut function if linear_exact.The viewer will fall back to default value linear when voi lut function is not present.This fix was already made available through an optional software upgrade r11.1.03 which was released in q2-2024 via (b)(4).The customer was informed that this software upgrade was already available for them to be implemented.We have received confirmation from the customer that after implementation of this service pack the issue has been resolved.

• 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: 20010896
• Report Number: 3003768277-2024-04529
• Device Sequence Number: 12577188
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 884838090040
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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
• Device Model Number: INGENIA AMBITION X
• Device Catalogue Number: 781356
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 12/16/2024
• 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 Sex: Unknown