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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Information received a smiths medical patient monitoring|bci capnography monitor capnocheck ii - 8400 keeps turning off.No patient adverse events reported.
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Manufacturer Narrative
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Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device speaker was loose and the c02 pump was found dislodged.The customer stated problem was duplicated.The reported complaint was verified after powered on the returned 8401 monitor and the monitor would reboot.Opened the monitor didn't notice anything wrong with the device.The main board was swapped with a good known test board and the device was able to power up correctly.The c02 pump was found dislodged and the speaker was loose.All evidence leads to impact to the monitor.Replace main board, repair speaker.The cause of the reported problem was traced to user manipulation of the device (impact).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 (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-09178.The report was submitted in error.
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Search Alerts/Recalls
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