Model Number BL2351 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The field service technician on site could not reproduce the reported problem.As precaution all connections were secured on top of power supply.Replaced electrical cord, as the cord was old.The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
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Event Description
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The system shutdown twice during surgery.No patient impact reported or medical intervention required.They changed out the power strips as a pre-caution.
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Manufacturer Narrative
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The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
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Search Alerts/Recalls
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