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Model Number ENSITE-SYSTEM-01 |
Device Problems
Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The cause of the reported communication issues was not able to be determined as the compact disc needed to investigate the event was not returned.For the reported event of electrical interference, review of the ensite system shows that adjusting the metal environment near the patient, such as raising the flat detector, may resolve the issue.If necessary, resetting the metal baseline should resolve the issue.The software was noted to be functioning as designed.For the reported mapping issue, collecting more voxels when entering a new area, such as a vein, will help increase the validity of the catheter.The catheter visualization changes depending on the density of voxels surrounding each catheter.When the density of voxels is low, the catheter will show in a low confidence state.When the density of voxels is high, the catheter will show in a high confidence state.The software was noted to be functioning as designed.
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Event Description
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Related manufacturer ref: 2184149-2021-00387.During a paroxysmal atrial fibrillation ablation procedure, mapping, error messages, electrical interference, and communication issues occurred that caused a clinically significant delay.Despite the issues and troubleshooting that was attempted to resolve them, the procedure was still successfully completed with no adverse consequences to the patient.
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Search Alerts/Recalls
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