Catalog Number 425-00 |
Device Problem
Power Problem (3010)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/02/2015 |
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 11/04/2009.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 had intermittent power issues prior to use.There was no patient involvement reported.
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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 no issues were observed.Functional testing was also performed and the unit was connected to 110 vac.The unit passed the initial power connect test, and 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 functioned with no interruptions for 2 hours and was turned off.The following day the unit would not restart.This scenario is indicative of a power supply pcb failure.The on-board power supply pcb was by-passed with a known good power supply pcb.The unit was restarted and successfully negotiated all pre-operational self-tests.Based on the investigation performed, the reported complaint has been confirmed.The power supply pcb is defective.All units being returned for service will have power supply pcbs replaced if they are older than 3 years.This unit was manufactured 16 feb 2009 and will be replaced.
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Event Description
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The event is reported as: the unit had intermittent power issues prior to use.There was no patient involvement reported.
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Search Alerts/Recalls
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