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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(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 unit was "not powering on".No patient involvement reported.
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Event Description
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It was reported unit was "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 it was observed that the right and left wing plastic brackets on the unit were damaged.No other defects were observed.Functional testing was performed and the unit was connected to 120vac.The unit passed the initial power connect test; however, the unit would not turn on.The power supply board was bypassed with a known good lab inventory board and this time the unit navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.The reported complaint of "unit will not power on" is confirmed.The sample was returned with a defective power supply pcba.A device history record review was performed with no evidence to suggest a manufacturing related issue.Each concha neptune device is inspected 100% during manufacturing assembly; therefore , it is unlikely that this defect was present at the time of release.The sample was manufactured in 2008 and was designed for a minimum of 5 years.Based on the information available, it appears that unintentional user error - normal wear caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
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Search Alerts/Recalls
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