Catalog Number 8603800 |
Device Problems
Gas Output Problem (1266); Leak/Splash (1354); Device Displays Incorrect Message (2591)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.We will provide results in a separate follow-up-report.
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Event Description
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It was reported that the device generated a check vent.Assembly alarm during use, indicating a relevant leak.There was no patient injury reported.
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Manufacturer Narrative
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The device was subject to a long-term test run in the manufacturer's lab.The reported behavior could be duplicated - the device detected sporadic deviations of more than 25% between the tidal volume applied by the ventilator and the volume readings of the inspiratory flow measurement.Corresponding alarms ("check vent assembly") were posted as reported by the user.The issue could be narrowed down to a chipped ceramic disc in one of the valves inside the compact breathing system (cosy).The sharp contour edge of the missing fragment was sporadically jamming inside the cage that keeps the valve disc in place.This jamming resulted intermittently in loss of volume and pressure during automatic ventilation because the valve did sometimes not close properly when intended.It can be concluded that the device responded as designed to the restriction of automatic ventilation; corresponding alarms were posted.As the valve is permanently open during manual ventilation the particular deviation does not come into effect in this mode.The root cause for the damage of the ceramic disc could not be determined during the course of investigation.The cosy has to be partly disassembled for reprocessing - hence, disassembly, cleaning/disinfection process and reassembly would be imaginable steps where the crack might have occurred.Post market surveillance data reasonably suggests the suitability of the design since there is no comparable case of a medical device vigilance report known.
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Event Description
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Please refer to initial mfr.Report #9611500-2018-00218.
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Search Alerts/Recalls
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