Model Number IPN913776 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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It was reported the unit is "not powering on".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 there were no major defects observed.Functional testing was performed and the unit was connected to 120vac.The unit did not pass the initial power connect test.The unit also did not pass the power-on self-test (p.O.S.T.).The power button was not illuminating and when pressed, the unit did not power on.The unit was opened and the power supply board was replaced with a known good lab inventory board.This time the unit was able to pass the power-on self-test with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.The complaint has been confirmed.The investigation revealed a defective power supply board.Since the neptunes are 100% functionally tested during manufacturing assembly, it is unlikely that the failure was present at the time of release.A device history record review was performed with no evidence to suggest a manufacturing related issue.It is possible the unit encountered excessive stresses during use, causing it to fail prematurely.The root cause for the failure is unknown.Eleflex will continue to monitor and trend on complaints of this nature.
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Event Description
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It was reported the unit is "not powering on".No patient involvement reported.
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Search Alerts/Recalls
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