Catalog Number 425-00 |
Device Problem
Power Problem (3010)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/16/2015 |
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 10/05/2007.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: the unit intermittently turns on and off.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 no defects were observed.Functional testing was also performed and the unit was connected to 110 vac.The unit failed the initial power connect test with no electrical response at all.The unit was opened to perform a power supply pcb by-pass test, however upon disconnecting the power supply wiring harness, the connector crumbled.The brittle condition is the result of heat over a long period of time.Testing could not continue.Based on the investigation performed, the reported complaint was confirmed.The investigation revealed a defective electronic component.The root cause for the failure is unknown.A conclusion code could not be found as the complaint was confirmed; however, a root cause could not be determined.
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Event Description
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The event is reported as: the unit intermittently turns on and off.Unknown when alleged defect was detected.
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Search Alerts/Recalls
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