Catalog Number 425-00 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2020 |
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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The complaint is reported as: there is an issue with the temperature probe causing the unit to alarm.The issue was detected prior to use on a patient during pre-testing.No patient involvement.
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Event Description
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The complaint is reported as: there is an issue with the temperature probe causing the unit to alarm.The issue was detected prior to use on a patient during pre-testing.No patient involvement.
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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 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.No abnormal alarms were observed.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
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Search Alerts/Recalls
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