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

Model Number 728246

Device Problem Defective Component (2292)

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 pr# (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 band artifact on patient images during head scans and an x-ray system can't comply issue (addressed in (b)(4)).There was no report of misrepresentation as a result of the band artifacts.The philips field service engineer (fse) evaluated the system and determined there was a crack in the compensator.The fse replaced the a-plane collimator and ran a full calibration to resolve the issue.The philips field service engineer (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 was determined not to be a reportable 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
• MDR Report Key: 7234774
• MDR Text Key: 98888383
• Report Number: 1525965-2018-00178
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K012009
• 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: 01/09/2014

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 01/09/2014
• Supplement Dates FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1