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Model Number 27076 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vomiting (2144); Loss of consciousness (2418)
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Event Date 01/04/2022 |
Event Type
malfunction
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Event Description
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The user facility reported that during a patient procedure involving the accutron digital flushmount flowmeter, the patient began to vomit and became unresponsive.The procedure was stopped and medical interventions were administered.
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Manufacturer Narrative
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The patient subject of the event sought medical evaluation following the reported event.Following the event, the technician noted that gas appeared to continue to flow and the bag appeared to inflate after the flowmeter had been powered off.A new flowmeter unit will be installed at the user facility.The digital flushmount flowmeter instructions for use states, "to be used only by a professional trained in the use of nitrous oxide, using titration method.Patient should always be closely monitored during nitrous oxide use.If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed.The o2 flush button can be used to rapidly purge the lines of n2o." the unit subject of the event is being returned to accutron.A follow up report will be submitted with information regarding the unit condition and evaluation upon receipt of the device.
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Manufacturer Narrative
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The unit was returned to accutron for evaluation.The evaluation found that an amplifier on the main circuit board was not operating properly resulting in the reported event.The cause of the failure of the component could not be determined.Possible causes of the failure include voltage spikes in facility power or mechanical shock (physical damage) from being dropped or impacted.The digital flushmount flowmeter instructions for use states, "to be used only by a professional trained in the use of nitrous oxide, using titration method.Patient should always be closely monitored during nitrous oxide use.If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed.The o2 flush button can be used to rapidly purge the lines of n2o.If patient does not show signs of quick recovery, remove nasal hood and treat with pure oxygen from either the o2 resuscitator fitting or an auxiliary oxygen tank using a demand valve, oxygen assisted manual resuscitator, or equivalent.Call for emergency assistance if rapid response is not achieved.".A review of complaints indicates this to be an isolated event.A new unit was installed at the user facility.No additional issues have been reported.
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Search Alerts/Recalls
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