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

Model Number 728235

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 pr# (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 intermittently, during clinical use, artifacts appeared on head studies.It was confirmed by the philips national support specialist (nss) the compensator 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 an artifact.Therefore, this issue has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

The customer reported that patient images exhibited a ring artifact.The philips field service engineer (fse) evaluated the system and confirmed the compensator had cracked and failed.The fse visually inspected the system and found a cracked compensator in the a-plane collimator.The fse replaced the a-plane collimator to resolve the issue.The philips fse confirmed there was no harm to a patient, operator, or bystander.The system is in clinical use.This issue was determined not to be a reportable event.

• Brand Name: BRILLIANCE 40
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7214707
• MDR Text Key: 98404718
• Report Number: 1525965-2018-00019
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K033326
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728235
• Device Catalogue Number: NCTA402
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1