Model Number CH00000001 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the blue circular dome on the back of the f gen light head fell outside of a case; there were no reported adverse consequences.(b)(4) were opened to review and address this issue.This light is within scope of the field action.
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Event Description
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It was reported the back cover for the light came off exposing the wires and motherboard.There were no reported injuries or patient involvement.
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Event Description
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It was reported the back cover for the light came off exposing the wires and motherboard.There were no reported injuries or patient involvement.
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Manufacturer Narrative
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There has been a corrected data update made to the following field: results code grid.
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Search Alerts/Recalls
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