Model Number 86620 |
Device Problem
Power Conditioning Problem (1474)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/23/2023 |
Event Type
malfunction
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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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During procedure, a clearsign ii amp, 80 channels was selected for use.It was reported that signal interference of body surface was found.The procedure was not completed due to this issue.The patient is stable, no patient complication or other additional intervention reported.Unknown if product is going to be returned.
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Manufacturer Narrative
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Product was not returned but was analyzed on site.Based on the work order, the interference was caused by the loose head of the body surface cable.Replaced a set of body surface cable and the fault was resolved.H3 other text : device was analyzed on site.
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Event Description
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During procedure, a clearsign ii amp, 80 channels was selected for use.It was reported that signal interference of body surface was found.The procedure was not completed due to this issue.The patient is stable, no patient complication or other additional intervention reported.The console has not been returned for analysis.
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Search Alerts/Recalls
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