Model Number 86620 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that prior to a procedure a clearsign ii amp, 80 channels presented an error at the time to start it.The procedure was cancelled due to the issue.No patient complications were reported.Device return status is unknown.
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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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Event Description
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It was reported that prior to a procedure a clearsign ii amp, 80 channels presented an error at the time to start it.The procedure was cancelled due to the issue.No patient complications were reported.Device return status is unknown.It was further reported that no patient was present in the case.The observed event was due to the power supply.Part will be returned.
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Search Alerts/Recalls
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