MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. BRILLIANCE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number BRILLIANCE CT BIG BORE

Device Problems No Apparent Adverse Event (3189); Program or Algorithm Execution Problem (4033)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).

Event Description

This complaint has been evaluated based on the information provided; the issue reported was that after upgrade to sp2, there's a change in position (shift) in 3 different software (mim, monaco and volume tool (inhouse sw for delineation)) after this upgrade due to a difference in the x and y coordinates.The difference (x-y) determines the shift in both directions.There's no report of injury or harm.However, oncology patients whose initial/early treatment plans may be compromised by the resulting interference with the user¿s ability to identify the image position and the potential mistakes in planning of subsequential oncology treatment.Therefore, we are voluntarily reporting this event out of abundance of caution.Philips has started an investigation of this complaint.

Manufacturer Narrative

The complaint stated after upgrade to sp2, when customer conducted phantom test and performed an offline reconstruction for the existing raw data and then compared the image in the 3rd party tps (therapy planning solution) software, customer noticed that there was a crossline shift in the tps.Customer checked and found there¿s no shift in ct viewer(a viewer software integrated into console software to load images and view them).After the issue reported, customer was asked to roll back to previous sw version.Technical investigation indicates that the position vector of image position (patient) tag (0020,0032) was wrongly calculated in the ct console software.As a result, the position tag of generated digital imaging and communication in medicine (dicom) images may be incorrect under specific clinical scenarios.Probable cause: image position tag was wrongly calculated in the ct console software.Corrective action: - correction and removal has been issued to update the software from 4.8.0.10421 to v4.8.0.10430 to correct the issue.

Event Description

The complaint stated after upgrade to sp2, when customer conducted phantom test and performed an offline reconstruction for the existing raw data and then compared the image in the 3rd party tps (therapy planning solution) software, customer noticed that there was a crossline shift in the tps.Customer checked and found there¿s no shift in ct viewer(a viewer software integrated into console software to load images and view them).After the issue reported, customer was asked to roll back to previous sw version.There's no report of injury or harm due to this issue.However, oncology patients whose initial/early treatment plans may be compromised by the resulting interference with the user¿s ability to identify the image position and the potential mistakes in planning of subsequential oncology treatment.Therefore, we are voluntarily reporting this event out of abundance of caution.Philips has now completed the investigation of this complaint.

• Brand Name: BRILLIANCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.; advanced technology center; matam building 34; haifa 31002 02; IS 3100202
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.; advanced technology center; matam building 34; haifa 31002 02; IS 3100202
• Manufacturer Contact: estelle hilas ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 17831550
• MDR Text Key: 324451431
• Report Number: 3008581796-2023-00001
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K171850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BRILLIANCE CT BIG BORE
• Device Catalogue Number: 728244
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0292/0294-202
• Patient Sequence Number: 1