Catalog Number MK06000 |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still on-going.The results will be provided within a follow-up report.
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Event Description
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It was reported that the screen was frozen during a case.The patient had to be hand bagged.Reportedly no information about alarms.No patient injury reported.
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Manufacturer Narrative
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Front cover including touch panel have been replaced and forwarded to the manufacturer for investigation.The parts were installed into the periphery of a lab device.The reported malfunction could not be confirmed in a 7-days endurance run.There was no other information made available in regard to the course of event; an electronic log file was also not provided.The reported event of unresponsive touch screen could not be duplicated with the original parts.Consequently, a reliable conclusion in terms of root cause for the event can't be drawn.Since the parts were replaced in the particular device to enable investigation a potentially existing device problem was solved.In case of unresponsive touch screen an ongoing ventilation episode would be continued with the last valid settings.The user however may switch the device to standby mode, set oxygen and anesthetic agent flow manually and continue patient support with the integrated breathing bag.Monitoring functionality remains available as well.This is described in the ifu chapter "operation in case of emergency".
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Event Description
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Refer to initial mfr.Report #9611500-2017-00333.
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Search Alerts/Recalls
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