Catalog Number MK06000 |
Device Problems
Gas Output Problem (1266); Decrease in Pressure (1490); No Pressure (2994); Intermittent Communication Failure (4038)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation has just started; results will be provided in a follow up-report.
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Event Description
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It was reported that during use on patient the display of the device went off unexpectedly and that the ventilation stopped.No injury reported.
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Manufacturer Narrative
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The investigation was based on log file analysis.It could be revealed that the workstation passed the system test in the morning of the date of event w/o deviations.The case in question was started at 09:17am system time.At 02:10pm the supervisor software triggered a reboot of the entire device due to the fact that a communication interrupt between the pcb that controls the therapy functions and the user interface (display and touchscreen) was detected.The system resumed therapy with the latest valid settings within 15 seconds after the reboot.From 02:13pm the patient was manually ventilated using man/spont.At 02:19pm the unit was placed into standby, finally.The device is back in use w/o further problems reported since then.It could finally not be determined under which exact circumstances the communication interrupt between the two functional units occurred.A persistent error condition can be excluded since the device is back in use.A reasonable explanation would be that electrostatic discharge or any other electromagnetic disturbance may have caused the phenomenon.This kind of events usually leaves no footprints in the log file as long as it does not lead to destroying of an electronic part.A reliable conclusion in regard to the root cause is however not possible.
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Event Description
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Please refer to initial mfr.Report #9611500-2019-00441.
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Search Alerts/Recalls
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