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Model Number ENSITE-SYSTEM-111 |
Device Problem
Electromagnetic Interference (1194)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2022 |
Event Type
malfunction
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Event Description
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During the procedure with the patient prepped, metal distortion was noted and the case was cancelled.The table was adjusted, the c-arm, monitor, iv poles, carts and booms were moved.Metal distortion would lower with everything moved away, but increased after several minutes with the equipment still moved away.The case was abandoned with no harm to the patient.
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Event Description
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This occurred during an atrial flutter ablation procedure.
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Manufacturer Narrative
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The collect logs were provided and reviewed.Review of the files show there were metal distortion errors regarding the prs-a becoming invalid.Adjusting the metal environment near the patient such as raising the flat detector may resolve the issue.Navigate to the prs setup screen and ensure all line items are green.If necessary, resetting metal baseline should resolve the issue.We understand your concerns and will take it under advisement.The software is functioning as designed.See ensite x ep system ifu, setup, system tab - metal sub-tab.
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Search Alerts/Recalls
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