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Model Number 8401 |
Device Problem
Power Problem (3010)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported that a smiths medical capnograph won't turn on.No adverse patient effects were reported.
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Manufacturer Narrative
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Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.However, a c02 sensor error displayed and the c02 pump would not run.Internal inspection of the monitor found the c02 bench screw holder cracked and was disconnected from the main board.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.
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Manufacturer Narrative
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This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10314.The report was submitted in error.,.
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Search Alerts/Recalls
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