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Model Number 9004050 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that a smiths medical capnograph was not giving any readings.No adverse patient effects were reported.
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Manufacturer Narrative
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Other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The main board was found to be malfunctioning, causing the co2 readings unable to be acquired.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.
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Manufacturer Narrative
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Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.Please disregard the initial report submitted with the mfr number: 3012307300-2021-10243.The report was submitted in error., corrected data: corrected information provided in h10.
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Search Alerts/Recalls
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