Catalog Number 105200-000030 |
Device Problem
Deflation Problem (1149)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/29/2019 |
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 complaint alleges the device 'would not deflate/reinflate on 8/10 attempts'.Alleged issue reported detected during functional testing prior to a patient use.No patient impact or consequence was reported.
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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.
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Event Description
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Customer complaint alleges the device 'would not deflate/reinflate on 8/10 attempts'.Alleged issue reported detected during functional testing prior to a patient use.No patient impact or consequence was reported.
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Search Alerts/Recalls
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