Catalog Number 425-00 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/19/2016 |
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 product was not returned.The device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on similar complaints.
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Event Description
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The customer alleges that the device is not registering a connection to the patient.No patient injury 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 defects observed.Functional testing was performed and the unit was connected to 110vac.The unit passed the initial power connect test and 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.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
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Event Description
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The customer alleges that the device is not registering a connection to the patient.No patient injury reported.
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Search Alerts/Recalls
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