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

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.(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 alleged that there was smoke coming from the gantry and the fire department was called.Philips field service engineer (fse) evaluated the ct system and could find evidence of anything that burned or smoked.Test scans were completed by the fse without issue.At this time there is no indication that a malfunction has occurred.Based on the available information, this issue has been initially determined to be a reportable event.This issue is currently under investigation.

Manufacturer Narrative

A technologist reported they heard over the intercom system there was smoke in the ct room and the fired department was called.The philips remote system engineer (rse) spoke with the customer on (b)(6) 2019 and it was confirmed all power to the system was shut off at that time.The operator stated the system has been shut down to the wall breaker.This occurred late in the evening on a saturday and the system did not need to be used the rest of the night.The philips field service engineer (fse) arrived on (b)(6) 2019 to inspect the system and found no system failures and no evidence of burnt system components that could have caused smoke.Several test scans were successfully completed and the system was ready for clinical use.A repeat visit was made by another fse to discuss the reported event with the facilities department and confirm the system was safe for use.It was confirmed by the fse the fire department was not dispatched to the customer site.The fse found no issues.No probable cause could be determined.The system is in clinical use.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: derrick massuri ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 8615737
• MDR Text Key: 145365178
• Report Number: 1525965-2019-00020
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2019
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1