Catalog Number 8607500 |
Device Problems
Gas Output Problem (1266); Failure to Deliver (2338); Ventilation Problem in Device Environment (3027)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.We will provide results in a separate follow-up report.
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Event Description
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It was reported that there was a ventilator failure during use.There was no injury reported.
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Manufacturer Narrative
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The log file evaluation suggested that the ventilator failure was related to a deviation detected by the piston position supervisor function.Two instances of a motor encoder check error have occurred during the concerned procedure which resulted in the observed shut-down of automatic ventilation.Consequently, the local service organization was advised to replace the motor assembly and return the suspected item to the manufacturer for deeper investigation.It could be determined that there was oil on the encoder disc which led to counting errors of the increments from which the actual motor position is being derived.To prevent from serious mechanical damages to the ventilator unit the system is designed to force a shut-down of automatic ventilation once the calculated actual motor position does not match with the expected one.This shut-down is accompanied by a corresponding visual and audible alarm.Manual ventilation as well as the monitoring functions remain available to the full extent.It was furthermore determined that the problem was of intermittent nature only - the device was power-cycled by the user after the event and was used for another six hours that day without exhibiting any further problems.Dräger finally concludes that the device behaved as specified for the particular failure mode.No patient consequences have occurred since device function could be restored.The replacement of the motor unit has fully solved the device problem.The presence of oil could be linked to the manufacturing process and preventive actions have been initiated.The failure rate is within accepted range.
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Event Description
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Please refer to initial mfr report #9611500-2018-00217.
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Search Alerts/Recalls
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