MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 6/10/16/16P; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Catalog Number 865214

Device Problem Signal Artifact/Noise (1036)

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

Event Type  malfunction  

Manufacturer Narrative

Internal cross reference: (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 a ring artifact appeared on abdomen images.There was no misrepresentation as a result of the artifact.A philips field service engineer (fse) went onsite to evaluate the system.The fse confirmed the customer¿s allegation.The fse visually inspected the system and found a crack in the compensator of the a-plane collimator.The fse determined that the cause of the artifact on the images was due to the crack in the compensator.The fse replaced the a-plane collimator and performed air calibrations and test scans successfully resolving the issue.The fse confirmed there was no patient harm.The system is functional and in clinical use.This issue has been determined not to be a reportable event.

• Brand Name: BRILLIANCE AIR 6/10/16/16P
• 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: 7250850
• MDR Text Key: 99608003
• Report Number: 1525965-2018-00342
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 865214
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1