MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 6 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728256

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.A philips field service engineer (fse) reported that during planned maintenance (pm), the gantry microphone was not working.The fse confirmed that the patient could not be heard by the operator due to this issue.If the operator is unable to hear the patient due to a failed microphone, there is potential for injury to the patient.This issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

The customer reported on (b)(6) 2018 that the gantry microphone would need to be replaced when the philips field service engineer (fse) came onsite to perform the planned maintenance (pm) as the gantry microphone was not working and the operator was unable to hear the patients.During the pm, the fse confirmed the gantry microphone was not working.This issue occurred on a brilliance 6air ct system.The customer confirmed with the philips help desk (when this issue was reported) that there was no patient impact and no harm as a result of this event.A philips fse arrived at the customer site on (b)(6) 2018 to perform the pm and evaluate the gantry microphones.The fse confirmed that the patient could not be heard by the operator due to this issue.The fse completed the pm and replaced the front and rear gantry microphone assembly to correct the malfunction.There was no report of harm to a patient, operator, or bystander as a result of this event.The philips fse determined that the operator could not hear the patient due to an intercom failure resulting from a malfunction of the front and rear gantry microphone assembly.The system is operational and in clinical use.The trained professional is instructed and trained to monitor the patient throughout the procedure.The operator¿s console area is designed to permit viewing of the patient at all times during the exam.The patient¿s condition, irrespective of the intercom system, may preclude their ability to orally communicate (e.G., they may be unconscious, patient age may prevent them from communicating).This event has been determined to no longer be a reportable event.

• Brand Name: BRILLIANCE 6 AIR
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7366906
• MDR Text Key: 103591193
• Report Number: 1525965-2018-00376
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K012009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728256
• Device Catalogue Number: NCTA396
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1