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

Device Problem Crack (1135)

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.Internal cross reference: complaint (b)(4).

Event Description

The customer reported that a ring artifact appeared on head scan images.The philips field service engineer (fse) determined that the compensator in the a-plane collimator was cracked.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 that a recognized ring artifact appeared on head scan images.A philips field service engineer (fse) went onsite to evaluate the system.The fse evaluated the system and was able to determine that the compensator in the a-plane collimator was cracked.The fse replaced the compensator inside the a-plane collimator to resolve the issue.The fse confirmed that there was no harm to a patient, operator, or bystander and there was no 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: 7171749
• MDR Text Key: 96729108
• Report Number: 1525965-2018-00006
• 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: 12/19/2017

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1