MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	728323
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Internal cross reference: complaint pr# (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that there was noise from the ct box speaker due to gantry electronics/fan sounds without any input from the microphone; therefore, the speaker volume was turned down.If the operator is unable to hear the patient due to the volume being turned down to a minimum, there is potential for injury to the patient.This issue has been determined to be a reportable event.This event is currently under investigation.
Additional Manufacturer Narrative
On (b)(6) 2017, the customer reported there was noise coming from the ct box speaker.The customer confirmed that they were able to hear the patient¿s voice through the ct box over the background noise, and there was no harm to a patient, operator or bystander as a result of this event.A philips field service engineer (fse) evaluated the ct system and determined that the 4 channel gantry audio board had failed.The fse replaced the 4 channel gantry audio board and the issue was resolved.The system is operational and in clinical use.This event has been determined not to be a reportable event.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7139620
• Report Number: 1525965-2017-00153
• Device Sequence Number: 1013978
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: (01)00884838059504
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 728323
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1