MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. INGENUITY CORE128; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 728323

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

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 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 ring artifact appeared in clinical images.A 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 issue.The fse evaluated the system and determined the cause of the artifact to be a crack in the a-plane collimator.The fse replaced the a-plane collimator and performed system calibrations.Following successful test scans, the system was returned to clinical use.This issue has been determined not to 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.The report source has also been updated.The customer reported a ring artifact appeared in clinical images.A 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 issue.The fse evaluated the system and determined the cause of the artifact to be a crack in the a-plane collimator.The fse replaced the a-plane collimator and performed system calibrations.Following successful test scans, the system was returned to clinical use.This issue has been determined not to 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.

• Brand Name: INGENUITY CORE128
• 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: 7104859
• MDR Text Key: 94954005
• Report Number: 1525965-2017-00082
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

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: 728323
• Device Catalogue Number: III
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 09/12/2016
• 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