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Model Number 728306 |
Device Problems
Signal Artifact/Noise (1036); Degraded (1153); Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Improper Device Output (2953); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).
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Event Description
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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.
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Manufacturer Narrative
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The customer reported intermittent artifacts on patient images.There was no report of misrepresentation as a result of the artifacts.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 reported issue.The fse confirmed that ring artifacts were present on scan images in the region of interest.The fse visually inspected the system and found a crack in the compensator of the a-plane collimator.The a-plane collimator was replaced and calibrations run to resolve the issue.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.
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Manufacturer Narrative
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The device has been evaluated by the manufacturer.The report source was also updated.The customer reported intermittent artifacts on patient images.There was no report of misrepresentation as a result of the artifacts.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 reported issue.The fse confirmed that ring artifacts were present on scan images in the region of interest.The fse visually inspected the system and found a crack in the compensator of the a-plane collimator.The a-plane collimator was replaced and calibrations run to resolve the issue.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.
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Search Alerts/Recalls
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