Model Number 001158-10A |
Device Problems
Increase in Pressure (1491); Failure to Deliver (2338); Device Operates Differently Than Expected (2913)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 05/31/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through distributor.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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Internal report number: (b)(4).Tentative summarizing translation from initial reporter's narrative: anaesthetic drug can not be delivered, pressure of injection device too high/ catheter possibly blocked.
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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).Anaesthetic drug can not be delivered, pressure of injection device too high/ catheter possibly blocked.
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Search Alerts/Recalls
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