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Catalog Number 425-00 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Information (3190)
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Event Date 10/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor, and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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The complaint is reported as, the unit "keeps alarming and stays at 22 degrees." it is unknown at this time when the issue was detected.
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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), 2-3 lpm of air pressure, and a 382-10 universal water column was connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests again and was functioning in real time.The settings were set to full rainout, invasive, at 37 degrees c.The unit functioned without any interruption or functional anomalies for ~2.0 hours.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
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Event Description
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The complaint is reported as: the unit "keeps alarming and stays at 22 degrees." it is unknown at this time when the issue was detected.
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Search Alerts/Recalls
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