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Model Number 8400D |
Device Problem
Failure to Sense (1559)
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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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Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device.A product sample was received for evaluation.Visual inspection and functional testing were performed.No physical damage was observed.The technician powered on the device and performed flowrate test, occlusion test and high/low calibration test.The technician found out that there was no flowrate and device received error while performing high/low calibration test.The reported issue of error-co2 sensor was duplicated.The technician replaced the pump to resolve the reported issue.The device passed all the functional test.The root cause of reported issue was determined to be related to defective co2 pump mechanism no longer drawing any airflow due to end of its useful life after 8 years of consistent operation.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 there was co2 sensor error on reported device.No patient injury was reported.
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Search Alerts/Recalls
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