Catalog Number 050-12R |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2020 |
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.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: the unit is not heating prior to patient use.No patient involvement reported.
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Event Description
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The complaint is reported as: the unit is not heating prior to patient use.No patient involvement reported.
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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 found that the thermal fuse was damaged.No other defects were observed.Functional testing was also performed and the unit passed all tests except for the current line and voltage requirements and leak test.Based on the investigation performed, the reported complaint was confirmed.During the investigation it was found that the thermal fuse was damaged.The unit did not exceed the temperature of 24.9 c - trying to reach the maximum value of temperature was not possible.The root cause could not be identified.
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Search Alerts/Recalls
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