Catalog Number 0620040610 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the insufflator was producing high level of co2.There was no adverse consequences and the case was completed successfully.
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Manufacturer Narrative
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Alleged failure: excessive co2.Probable root cause: pressure sensor malfunction/out of calibration.Software malfunction.Use error.System design.Unwanted movement of internal components/wiring.Insufflator operated at least-favorable environmental conditions for an extended period of time.Pressure button does not disengage.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.
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Event Description
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It was reported that the insufflator was producing high level of co2.There was no adverse consequences and the case was completed successfully.
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Search Alerts/Recalls
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