Catalog Number 8606000 |
Device Problems
Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still on-going.The results will be provided with a follow-up report.
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Event Description
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It was reported that during use, when the user pressed the switch to change the settings, the screen went black and the device restarted.After that, the device worked normally and the surgery was continued.No injury reported.
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Manufacturer Narrative
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The analysis of the device log has shown that on the date of event the device performed a software reboot.This event is logged if the cpu is reset due to a expired watchdog timer.In case this safety function is triggered the ventilator stops working.This is accompanied by an acoustical alarm and is also visible as the screen turns black.Subsequently, a self-test is performed by the device also containing a test of the loudspeaker what is audible for the user.After completion of the test the device switches to man/spont mode.As the requested parts were not provided for investigation finally, the root cause of the identified software reboot could not be identified.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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Event Description
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It was reported that during use, when the user pressed the switch to change the settings, the screen went black and the device restarted.After that, the device worked normally and the surgery was continued.No injury reported.
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Search Alerts/Recalls
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