Model Number 9004050 |
Device Problem
Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2021 |
Event Type
malfunction
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Event Description
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It was reported that the front panel down arrow is not working on a smiths medical capnograph.No patient involvement.
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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.After the keypad, sample line and main battery were replaced the device passed all functional tests.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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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: 3012307300-2021-11169.The report was submitted in error.
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Search Alerts/Recalls
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