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Catalog Number 425-00 |
Device Problem
False Alarm (1013)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.However, nine devices were taken from the current production, and functionally inspected.During testing, the issue "constantly alarming during use" reported was not observed in the current manufacturing process.A device history record investigation for serial number reported did not any show issues related to this complaint.A record assessment (fmea) was conducted and no update is required.Customer complaint cannot be confirmed.Root cause and corrective actions cannot be determined.If the device sample becomes available at a later date, this report will be updated accordingly.
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Event Description
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Customer complaint alleges the "orange water light constantly alarming, but temperature remained the same, water bottle full".Issue reported as occurred during patient use.No patient injury or consequence reported.Patient condition reported as fine.
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Event Description
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Customer complaint alleges the "orange water light constantly alarming, but temperature remained the same, water bottle full".Issue reported as occurred during patient use.No patient injury or consequence reported.Patient condition reported as fine.
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.The unit was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 10 lpm of air pressure, and a 382-10 universal water column is connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests again.The testing parameters were set as such: full rainout, invasive mode , temperature set at 37 c.The unit functioned without any interruption or functional anomalies for ~2.0 hours.No alarms were activated beyond normal self-diagnostic testing.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
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Search Alerts/Recalls
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