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

Model Number BIG BORE RT

Device Problem Insufficient Information (3190)

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

Event Date 08/25/2023

Event Type  malfunction  

Event 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.

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).

• Brand Name: BRILLIANCE
• Type of Device: 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
• MDR Text Key: 333825423
• Report Number: 3008581796-2024-00001
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838095168
• UDI-Public: 00884838095168
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BIG BORE RT
• Device Catalogue Number: 728242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2023
• 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
• Patient Sequence Number: 1