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

Model Number 728306

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

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

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, after patient scanning, a ring artifact appeared on scanned images.There was no report of misrepresentation as a result of the artifact.The philips field service engineer (fse) visually inspected the system and found broken pieces from the compensator in the collimator.The collimator was replaced and the system backup was successfully completed to resolve the issue.The fse confirmed there was no harm to a patient and no report of misrepresentation and/or mistreatment as a result of the reported issue.The system is in clinical use.This issue has been determined to not 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.Report source information has also been updated.The customer reported, after patient scanning, a ring artifact appeared on scanned images.There was no report of misrepresentation as a result of the artifact.The philips field service engineer (fse) visually inspected the system and found broken pieces from the compensator in the collimator.The collimator was replaced and the system backup was successfully completed to resolve the issue.The fse confirmed there was no harm to a patient and no report of misrepresentation and/or mistreatment as a result of the reported issue.The system is in clinical use.This issue has been determined to not be a reportable event.Please see sections d9, g2, h2, h3, and h6 for updated information and coding.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: ICT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: 7101087
• MDR Text Key: 94400771
• Report Number: 1525965-2017-00055
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

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: 728306
• Device Catalogue Number: NCTC780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 05/28/2017
• 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