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

Device Problems Degraded (1153); Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Output Problem (3005)

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

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.(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 a ring artifact displayed on patient images.There was no report of misrepresentation as a result of the ring artifact.The philips field service engineer (fse) evaluated the system and found that the compensator in the collimator was cracked causing the ring artifact.The fse replaced the collimator and completed a test scan to resolve the reported issue.The 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 system is in clinical use.This issue has been determined to not be a reportable event.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

The device has been evaluated by the manufacturer.The customer reported a ring artifact displayed on patient images.There was no report of misrepresentation as a result of the ring artifact.The philips field service engineer (fse) evaluated the system and found that the compensator in the collimator was cracked causing the ring artifact.The fse replaced the collimator and completed a test scan to resolve the reported issue.The 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 system is in clinical use.This issue has been determined to not be a reportable event.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the 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
• Manufacturer Contact: derrick massuri ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 7106230
• MDR Text Key: 94521522
• Report Number: 1525965-2017-00124
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1