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

Device Problem Signal Artifact/Noise (1036)

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

Event Type  malfunction  

Manufacturer Narrative

Note: 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 reported a ring artifact on brain studies.Engineering analysis has confirmed that this event has been determined to be a reportable issue due to the potential for image misinterpretation, because of a recognizable artifact.Therefore, this issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

The customer reported a recognized ring artifact on brain studies.A philips field service engineer (fse) went onsite to evaluate the system.The fse investigated the system and determined the ring artifact was the result of a cracked compensator which is inside the a-plane collimator.The fse replaced the a-plane collimator assembly to resolve the issue.The fse confirmed that there was no harm to a patient, operator, or bystander; there was no image misinterpretation as a result of the artifact.The system is functional and in clinical use.This issue has been 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: 7153909
• MDR Text Key: 96124991
• Report Number: 1525965-2017-00163
• 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
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1