Catalog Number 425-00 |
Device Problem
No Device Output (1435)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/04/2016 |
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 09/23/2010.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 temperature is not reading on the display panel.Unknown when alleged defect was detected.
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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 failed the initial power connect test.The unit was experiencing multiple front panel display light issues.Based on the investigation performed, the reported complaint was confirmed.The problem could be originating with the power control pcb, or the user interface front panel.All units being returned for service will have power supply pcbs replaced.This unit was manufactured 31 may 2010 and will be replaced.
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Event Description
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The event is reported as: the temperature is not reading on the display panel.Unknown when alleged defect was detected.
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Search Alerts/Recalls
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