MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRILLIANCE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	BRILLIANCE CT BIG BORE
Medical Device Problem Codes	No Apparent Adverse Event (3189); Noise, Audible (3273)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
This complaint has been evaluated based on the information provided.This issue reported was an interventional oncologist who spends extended periods of time in the bb ct room has developed tinnitus.Based on the available information, this issue has been initially determined to be a reportable event.Philips has started an investigation of the complaint.
Additional Manufacturer Narrative
A philips field service engineer went to the site and evaluated the system.The acoustic levels were acceptable; there was no system malfunction.The investigation is on-going.
Additional Manufacturer Narrative
Philips received a complaint on the brilliance big bore ct oncology system alleging that an interventional oncologist had developed bilateral tinnitus.The physician, who has worked on the system for six years, approximately three days a week for six hours a day, measured the level of noise emitted from the ct system through a phone app; the result was seventy decibels.Per the big bore planning reference document, the expected noise level at one meter from the gantry is 70 decibels.A philips field service engineer (fse) evaluated the system and confirmed there was no abnormal noise due to a system fault; the system was operating within specification.Noise levels were measured in the scan room with a sound level meter.The results, all within system specifications, were as follows: front of gantry: 65.4 dba (decibels a) rear of gantry: 68.8 dba coast down front of gantry: 69.6 dba coast down rear of gantry: 70.8 dba where physician stands: 67.3 dba gantry off: 49.0 dba the reported noise levels correspond with the expected noise levels for the device.A reported noise level of 70 decibels is within the national institute for occupational safety and health (niosh) standard for workplace safety, which defines an acceptable noise exposure level of 85 decibels for 8 hours per day, 5 days per week.Therefore, based on this information and the information contained in the record, the tinnitus experienced by the user cannot be conclusively traced to the use of the device.A review of the risk management file indicates the issue to be of low potential severity, which would not reasonably cause or contribute to death or serious injury if the problem were to reoccur.Therefore, based on the conclusion of this investigation, this issue has been determined not to be a reportable event.

• Brand Name: BRILLIANCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: estelle hilas ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19283137
• Report Number: 3015777306-2024-00003
• Device Sequence Number: 15292543
• Product Code: JAK
• UDI-Device Identifier: 00884838059450
• UDI-Public: 00884838059450
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/07/2024; 07/03/2024
• 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