Model Number 001156-81 |
Device Problems
Nonstandard Device (1420); Product Quality Problem (1506); Insufficient Flow or Under Infusion (2182); Failure to Infuse (2340); Manufacturing, Packaging or Shipping Problem (2975); No Flow (2991)
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Patient Problems
Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 05/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4) distributor (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
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Event Description
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(b)(4).Tentative summarizing translation of initial reporter's narrative: unable to inject, high resistance felt.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation, file is considered as closed.
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Event Description
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(b)(4).Tentative summarizing translation of initial reporter´s narrative: unable to inject, high resistance felt.
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Search Alerts/Recalls
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