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

Model Number 728231

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

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

Engineering analysis concluded that this event has the potential to result in image misinterpretation due to an artifact from a degraded compensator within the collimator.Therefore, this issue has been determined to be a reportable event.

Manufacturer Narrative

The customer reported that after a patient scan, a dark circular artifact appeared on the scanned images.There was no misrepresentation as a result of the artifact.A philips field service engineer (fse) confirmed there was no harm to a patient and no report of misrepresentation and/or mistreatment as a result of this reported issue.The fse confirmed that ring artifacts were present on scan images in the region of interest.The fse visually inspected the system, ran test scans, and found a crack on the compensator within a-plane collimator.The fse replaced the a-plane collimator and recalibrated the system to resolve the issue.The system was returned to clinical use.This issue has been determined not to be a reportable event.

• Brand Name: BRILLIANCE 64
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7084578
• MDR Text Key: 93843531
• Report Number: 1525965-2017-00035
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

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: 728231
• Device Catalogue Number: NCTB423
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 03/16/2015
• Supplement Dates FDA Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1