ST PAUL CAPNOCHECK PLUS SLEEP CARBON DIOXIDE DETECTOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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Model Number 8401 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/1901 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The monitor came in for ?failed co2 hi/lo calibration, co2 sensor malfunctioning" the customers comments were verified.The monitor was powered up and would not occlude, hooked up to a flowmeter and got 0 ml/min.Open the monitor and seen that the elbow was broken off the valve assembly and the pump was dislodged due to impact suffered to the monitor.The root cause of the reported issue was found to be the broken elbow on the valve caused by user interface.The valve assembly was replaced as corrective action.The broken co2 valve from within the device is consistent with unit being severely impacted from drop.The protective boot around the housing acts as shock absorber preventing damage to the housing; however centrifugal forces in the time of impact affect internal components which usually results in component damage.No information 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 the device failed co2 calibration, co2 sensor malfunction.No patient injury was reported.
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