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

Model Number	BIG BORE RT
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.It was reported that during the philips internal testing process, it was found that the ct series reconstructed with a x or y reconstruction offset per dicom private tag (01f1,100c), which can be used within tumor loc to transmit invalid absolute marking coordinates to a laser marking system.These invalid coordinates might result in an incorrect treatment location on the patient¿s skin.Based on the available information, this issue has been determined to be a reportable event.Philips has started the investigation of this event.
Additional 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 (b)(4).
Additional Manufacturer Narrative
This complaint has been evaluated based on the information provided; it was reported that the ct series reconstructed with a x or y reconstruction offset per dicom private tag (01f1,100c), which can be used within tumor loc to transmit invalid absolute marking coordinates to a laser marking system.This issue was identified during the philips internal testing process without patient invovlement.No similar issue has been reported by the customer.Philips has investigated this complaint.According to the investigation result, this issue only occurs when there is a recon offset in x or y, it will not occur when a recon offset in both x and y.The cause is that a logic error was found within the tumor loc codebase, which resulted in tumor loc blocking absolute marking functionality failure when there was a recon offset in either x or y, but the blocking absolute marking functionality worked as designed when a recon offset in both x and y.The intent of blocking absolute marking functionality was to block absolute marking when a recon offset was present.The code that computes absolute marking coordinates did not account for the offset in either x or y, but only for the offset in both x and y, producing incorrect coordinates.The system was not in clinical use when this occurred.A review of the risk management file indicates the problem reported by the customer is a low potential severity which would not reasonably cause or contribute to death or serious injury if the problem were to reoccur.Based on the information available and results of analysis, no further action is necessary at this time.
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.It was reported that during the philips internal testing process, it was found that the ct series reconstructed with a x or y reconstruction offset per dicom private tag (01f1,100c), which can be used within tumor loc to transmit invalid absolute marking coordinates to a laser marking system.These invalid coordinates might result in an incorrect treatment location on the patient¿s skin.Based on the available information, this issue has been determined to be a reportable event.Philips has now completed the investigation of this complaint.

• Brand Name: BRILLIANCE
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• 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: 18585099
• Report Number: 3008581796-2024-00001
• Device Sequence Number: 17900068
• Product Code: JAK
• UDI-Device Identifier: 00884838095168
• UDI-Public: 00884838095168
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171850
• 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: Risk Manager
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: BIG BORE RT
• Device Catalogue Number: 728242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 05/13/2024
• 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