Catalog Number MK06000 |
Device Problems
Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2022 |
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 a "turbovent2 failure" was displayed and ventilation stopped.No injury reported.
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Manufacturer Narrative
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The device log file analysis revealed that on the reported date of event a signal failure of the control responsible for the motor speed and motor direction occurred.The signal was not transmitted correctly leading to the reported turbo vent 2 failure.The device has reacted on the detected deviation as specified by posting a corresponding alarm.In this case automatic ventilation is no longer possible.Fresh gas and manual ventilation remain available.The sporadic failure could be traced back to a faulty component onboard the pcb a500 blower.The field-failure-rate of the pcb a500 blower is accepted by the responsible product quality board.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 a "turbovent2 failure" was displayed and ventilation stopped.No injury reported.
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Search Alerts/Recalls
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