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

Model Number	728306
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
The customer reported that after a patient head scan, a ring artifact appeared on the scanned images.There was no misrepresentation as a result of the artifact.A philips field service engineer (fse) went to the site to evaluate the system.The fse confirmed the customer¿s allegation and visually inspected the system.The fse found a crack in the compensator of the a-plane collimator.The fse determined that the cause of the artifact on the images was due to the crack in the compensator.The fse replaced the a-plane collimator to resolve the issue.The fse confirmed there was no patient harm.The system is functional and in clinical use.This issue has been determined not to be a reportable event.

• Brand Name: ICT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7102098
• Report Number: 1525965-2017-00098
• Device Sequence Number: 11100612
• Product Code: JAK
• UDI-Device Identifier: 00884838059474
• UDI-Public: (01)00884838059474
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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
• Operator of Device: Health Professional
• Device Model Number: 728306
• Device Catalogue Number: NCTC780
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1