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

Catalog Number III

Device Problems Signal Artifact/Noise (1036); Crack (1135)

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

Event Type  malfunction  

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 intermittently, ring artifacts displayed in ct head images.A philips field service (fse) confirmed the compensator was cracked and was causing the intermittent ring artifacts.Engineering analysis has confirmed that this event has been determined to be a reportable issue due to the potential for image misinterpretation, because of an artifact.Therefore, this issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

The customer reported that during a patient procedure, the images exhibited ring artifacts.The philips field service engineer (fse) evaluated the system and confirmed there was a crack in the compensator.The fse replaced the a-plane collimator to resolve the issue.The philips fse confirmed there was no harm to a patient, operator, or bystander.The system is in clinical use.This issue was determined not to be a reportable event.

• 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
• MDR Report Key: 7280733
• MDR Text Key: 100556301
• Report Number: 1525965-2018-00355
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K033326
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: III
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1