Model Number 86620 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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During a procedure a clearsign amplifier was selected for use.It was found that the device had a black screen.The procedure was not completed due to this event.The patient is stable, no patient complication or other additional intervention reported.Whether the date of the procedure was changed was unknown.
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Event Description
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During a procedure a clearsign amplifier was selected for use.It was found that the device had a black screen.The procedure was not completed due to this event.The patient is stable, no patient complication or other additional intervention reported.Whether the date of the procedure was changed was unknown.
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Manufacturer Narrative
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The device has not been received for analysis.However, a work order required a field service engineer (fse) to go on site.The fse received an error when starting up the system confirming the reported allegation.The software was reinstalled.Therefore, it can be concluded that software was the most probable cause of the event.
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Search Alerts/Recalls
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