Catalog Number 425-00 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned at the time of this report.The device history record (dhr) review did not show issues related to the complaint.The device was manufactured on 09/02/2009.A document assessment (fmea-08-037) was conducted and no changes were required.The reported complaint cannot be confirmed since the device sample is not available to perform a proper investigation, determine the root cause and assign corrective actions.If the device sample becomes available at a later date, this complaint will be updated accordingly.
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Event Description
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The event is reported as: the unit overheats during use.No harm or injury to patient reported.
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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 maintaining the set temperature for 45 minutes.The unit functioned without interruption.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 event is reported as: the unit overheats during use.No harm or injury to patient reported.
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Search Alerts/Recalls
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