ST PAUL CAPNOCHK II CAPNOGRAPH ONLY WITH BATT AND CHARGER; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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Model Number 8401 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.The device was returned for evaluation.Visual and functional tests were performed.The device was received in good physical condition and there was no damage.The report issue could not be duplicated.The root cause of the reported issue was found to be the main board.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that the device had an "error of co2".No patient injury was reported.
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Search Alerts/Recalls
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