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

Model Number 728243

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.The customer reported that the gantry microphone was not working and the patient could not be heard.Philips service confirmed that the microphone power control board failed and resulted in the operator not being able to hear the patient.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 that the gantry microphone was not working and the patient could not be heard.This issue occurred on a big bore (bb) oncology ct system.The customer confirmed with the philips help desk that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) evaluated the ct system while onsite and determined that the microphone assembly had failed.A new microphone assembly was ordered and a follow-up corrective maintenance visit was completed.The fse replaced the gantry microphone assembly to correct and resolve the malfunction.The system is operational and in clinical use.This event has been determined not to be a reportable event.

• Brand Name: BRILLIANCE BIG BORE ONCOLOGY
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7258768
• MDR Text Key: 99835125
• Report Number: 1525965-2018-00344
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K033357
• 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: 01/16/2018

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
• Device Operator: Health Professional
• Device Model Number: 728243
• Device Catalogue Number: NCTB104
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1