Catalog Number 8606500 |
Device Problem
Loss of Power (1475)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.We will provide results within a separate follow-up-report.
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Event Description
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The customer stated that the ventilator failed during a case after a power outage.The case was continued by bagging the patient.There was no injury reported.
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Event Description
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Please refer to initial mfr.Report #9611500-2018-00269.
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Manufacturer Narrative
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A draeger fse could confirm the issue upon on-site evaluation of the electronic log file nd has replaced the ventilator motor.The workstation passed all consecutive tests and is now back in use again.The replaced motor was handed over to the manufacturer for evaluation.Evaluation of the motor in the manufacturer's lab revealed that there were several positions where the motor did not provide mechanic power due to a mechanically abraded collector disc.The motor speed is being monitored continuously and, the speed fluctuations 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 which enabled the user to bridge patient support during the particular surgical procedure until a replacement device was made available.Dräger finally concludes that the device responded as specified upon the malfunction of a single wear-and-tear component; no patient consequences have been reported.The repair exchange of the motor assembly has fully solved the reported problem with automatic ventilation; some other deviations were rectified as well.Proper function of the entire device was verified by testing after the repair measures.Based on the log file evaluation the motor was operated for nearly 177% of the specified lifetime which can be considered well acceptable.
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Search Alerts/Recalls
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