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

Model Number 728246

Device Problems Signal Artifact/Noise (1036); 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

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

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

While on site to perform corrective maintenance for a table issue (addressed in pr8817008), the philips field service engineer (fse) found circular artifacts on scan images.The fse confirmed there was no harm to a patient and no report of misrepresentation and/or mistreatment as a result of the artifacts.The fse evaluated the system and determined a crack in the compensator of the a-plane collimator was causing the artifacts.The a-plane collimator was replaced to resolve the issue and the system was returned to the customer for clinical use.This issue was determined not to 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.While on site to perform corrective maintenance for a table issue (addressed in (b)(4)), the philips field service engineer (fse) found circular artifacts on scan images.The fse confirmed there was no harm to a patient and no report of misrepresentation and/or mistreatment as a result of the artifacts.The fse evaluated the system and determined a crack in the compensator of the a-plane collimator was causing the artifacts.The a-plane collimator was replaced to resolve the issue and the system was returned to the customer for clinical use.This issue was determined not to 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 16 AIR
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• 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: 7249473
• MDR Text Key: 99311323
• Report Number: 1525965-2018-00325
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K012009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

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
• Device Model Number: 728246
• Device Catalogue Number: NCTA399
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 12/02/2014
• 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