Catalog Number 8605310 |
Device Problems
Intermittent Continuity (1121); Gas Output Problem (1266); Loss of Threshold (1633); Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the analysis of the device logfile, the case could be reconstructed.It was found that the device forced a shutdown of automatic ventilation due to a detected wrong motor position.The motor speed is being monitored continuously; speed fluctuations caused e.G.By an abraded collector disc will result in a deviation between measured and expected piston position.To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported.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 the unit displayed a vent failure during a case.There was no patient injury reported.
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Manufacturer Narrative
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Additional information was received from the customer and was analyzed.It was found that the reported ventilation failure was not due to a faulty motor assembly as concluded in mdr report sent on november 29th, 2021, but due to a problem originated on the pcb vgc analog.As the replaced pcb vgc analog was not provided for investigation the exact root cause finally couldn¿t be determined.The incorrect motor position was detected by the device as expected and the corresponding ventilator fail alarm was displayed on the user interface and audible alarmed.In case of a ventilator failure during automatic ventilation, the ventilator initiates an autonomous shutdown while changing mode to man/spont (safety mode) and generating the appropriate ventilator fail alarm.Manual ventilation remains possible.The pcb vgc analog was replaced and the device returned to use without further problems reported.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported.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 the unit displayed a vent failure during a case.There was no patient injury reported.
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Search Alerts/Recalls
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