Catalog Number 425-00 |
Device Problem
Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/03/2015 |
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 04/28/2009.A document assessment ((b)(4)) 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's temperature cannot be adjusted 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 no defects were 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 neptune displayed the correct temperatures and properly alarmed in the high temperature scenario.The unit failed the functional bench testing.The power supply pcb was by-passed with a known good power supply pcb and the condition persisted.After eliminating the power supply pcb as possibly defective, it was determined the power control pcb, which controls the micro-processing functions for the heater, was defective.Based on the investigation performed, the complaint has been confirmed.It was determined that the power control pcb is defective.All units being returned for service will have the power supply pcbs replaced.This unit was manufactured 13 oct 2008 and will be replaced.
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Event Description
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The event is reported as: the unit's temperature cannot be adjusted during use.No harm or injury to patient reported.
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Search Alerts/Recalls
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