Catalog Number 425-00 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product usage when the alleged issue was detected is unknown.The device was received by the manufacturer for evaluation, but the results of the investigation are incomplete at the time of this report.The device history record investigation did not show issues related to complaint.
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Event Description
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The customer alleges that the unit will not recognize the probe.
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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 there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit failed the initial power connect test.When the power on button is released the unit immediately drops out with no response.This failure is indicative of a defective power supply pcb.The on-board power supply pcb was by-passed with a known good power supply pcb and the test was attempted again, this time successfully.Based on the investigation performed, the reported complaint was confirmed.It was determined that the power supply pcb is defective.All units being returned for service will have power supply pcbs replaced.This unit was manufactured 18 apr 2007 and will be replaced.
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Event Description
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The customer alleges that the unit will not recognize the probe.
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Search Alerts/Recalls
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