Catalog Number 425-00 |
Device Problems
Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The investigation into this complaint is in progress.The device involved in this complaint has not been returned to the manufacturer at the time of this report.
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Event Description
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Customer complaint alleges that the device "has recently only been operating intermittently with proper heating elements." complainant further elaborates the device is "experiencing intermittent power failure".It was reported the alleged malfunction was detected prior to use.There was no report of patient involvement.
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Manufacturer Narrative
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(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 low compliance column is connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit functioned without interruption for six 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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Customer complaint alleges that the device "has recently only been operating intermittently with proper heating elements." complainant further elaborates the device is "experiencing intermittent power failure".It was reported the alleged malfunction was detected prior to use.There was no report of patient involvement.
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Search Alerts/Recalls
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