Catalog Number 050-12J |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
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 "the temperature was below the defined one.(according to the rep, it was 121.7 degree c/max, although our range is from 124 to 127 degree c/max.)".No patient harm or injury reported.Patient condition reported as "fine".
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Event Description
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It was reported "the temperature was below the defined one.(according to the rep, it was 121.7 degree c/max, although our range is from 124 to 127 degree c/max.)".No patient harm or injury reported.Patient condition reported as "fine".
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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 it was observed that the device was used by the customer.No defects were detected.Functional testing was also performed and the device passed all tests.There were no heating issues found with the returned device.The unit functioned as intended.The complaint could not be confirmed.
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Search Alerts/Recalls
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