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

Model Number 728306

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.(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 a circle or swirl artifact on a ct head scan.A philips field service engineer (fse) identified a crack in the compensator assembly as the cause of the artifact.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 patient images exhibited a recognized ring artifact.There was no report of misrepresentation as a result of this issue.A philips field service engineer (fse) went onsite to evaluate the system.The fse found that the compensator inside the a-plane collimator had cracked.The fse determined that the cause of the artifact on the images was due to the crack in the compensator.The fse replaced the compensator to resolve the issue.The system is functional and in clinical use.This issue has been determined not to be a reportable event.

• Brand Name: ICT
• 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: 7130833
• MDR Text Key: 95532957
• Report Number: 1525965-2017-00147
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K060937
• 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: 11/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728306
• Device Catalogue Number: NCTC780
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1