Model Number 021159-20B |
Device Problems
Break (1069); Fracture (1260); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Mechanical Jam (2983); Device Handling Problem (3265)
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Patient Problems
Awareness during Anaesthesia (1707); Foreign Body In Patient (2687)
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Event Date 07/11/2016 |
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)(6).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 of initial reporter's narrative: catheter breakage.
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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: catheter breakage.
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Search Alerts/Recalls
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