BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
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Model Number 86620 |
Device Problems
Signal Artifact/Noise (1036); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure a clearsign ii amp, 80 channels was selected for use.The quadri probes were not recognized, and a noise artifact was detected.The procedure was cancelled.No patient complications were reported.This report is being sent due to the procedure cancellation.
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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