Catalog Number 048-91 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/18/2020 |
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.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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Customer reports heater "not heating up, does not produce any mist" during patient use.No patient harm reported.The unit was swapped out with another device.The patient's condition is stable.
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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 thermal fuse was damaged.Functional testing revealed the unit did not heat as the thermal fuse was open.This tends to happen when the unit is exposed to a period of time without the water container.The complaint has been confirmed.
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Event Description
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Customer reports heater "not heating up, does not produce any mist" during patient use.No patient harm reported.The unit was swapped out with another device.The patient's condition is stable.
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Search Alerts/Recalls
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