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Model Number 8401 |
Device Problem
Gas Output Problem (1266)
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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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The dhr review is not applicable or relevant 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 received for evaluation.Visual and functional testing were performed.Visual inspection found tamper seal was intact; however, there was a cracked battery compartment and loose speaker.Functional testing was able to duplicate the reported problem.The flow rate read 55 ml/min but the monitor was still occluded and passed leak testing.The root cause of the reported issue was found to be a leak in the pneumatics through cracked filter inlet port.The back case was replaced.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
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Event Description
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It was reported that there was high co2, unstable.No patient injury was reported.
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Search Alerts/Recalls
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