Catalog Number MEDICAL UNKNOWN |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Customer reported "unable to take any air out of the cuff" during demonstration on a mannequin.The device was inserted into the mannequin and the cuff pilot marker was in the red zone.The device was removed from the mannequin and another attempt was made to remove air.The cuff pilot marker remained in the red zone and would not come back down.
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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 reported "unable to take any air out of the cuff" during demonstration on a mannequin.The device was inserted into the mannequin and the cuff pilot marker was in the red zone.The device was removed from the mannequin and another attempt was made to remove air.The cuff pilot marker remained in the red zone and would not come back down.
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Search Alerts/Recalls
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