ST PAUL BCI CAPNOCHECK PLUS SLEEP CARBON DIOXIDE DETECTOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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Catalog Number 9004 |
Device Problems
Device Alarm System (1012); Mechanical Problem (1384)
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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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No product sample was received; therefore, no visual and functional testing could be performed.The reported issue could not be confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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 an occlusion was displayed, replaced filter, trap, absorber and braided tube.No patient injury was reported.
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Search Alerts/Recalls
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