Catalog Number 425-00 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/11/2016 |
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 08/13/2007.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: there is no check light prior to use.There was no patient involvement 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 also performed and the unit was connected to 110vac.At the initial power connection test the unit failed.It was noted that the accept check led light was not functioning on the front user face panel.The user interface pcb is defective causing the check light led to be inoperable.Based on the investigation performed, the reported complaint was confirmed.The investigation revealed a defective electronic component.A root cause for the issue could not be determined.
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Event Description
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The event is reported as: there is no check light prior to use.There was no patient involvement reported.
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Search Alerts/Recalls
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