It was reported that the event was caused due to a pooling of water in the tube when used in a cpap environment.This pooling of water may result in an increase in backpressure and therefore a reduction of flow reaching the patient which may cause the feeling of "less powerful" treatment.The report stated that the maxventuri alarmed (exp heater wire).It should be noted that the maxventuri does not contain an alarm system or connection to the exp heater wire.We were unable to gain information clarifying what product in the user's setup alarmed.Maxtec's complaint database from march 2008 to february 2021 did not identify complaints related to observations described in the report.The maude database was reviewed from march 2008 to february 2021, product code ccl: there were a total of 34 reportable events; 0 out of the 34 events pertained to the maxventuri; 0 out of the 34 events pertained to similar observations provided in the (b)(6) report.No information reviewed during the historical data analysis suggested that the root cause was related to the maxtec maxventuri.The (b)(6) report stated that the facility took actions that included checking tubing regularly and draining excess fluid away when the patient was on cpap.The manufacture or the manufacturer's part number listed in the (b)(6) report is not indicated as an approved circuit for use with our device as outlined in the instructions for use (ifu), r211m03 rev t, provided with the maxventuri.The probable root cause of the incident was off-label use which resulted from a failure to follow maxtec's instructions for use.We are unable to determine the exact point of failure in the user's setup.As the ifu clearly states the approved disposable interfaces to be used with the maxventuri, no corrective action has been deemed necessary regarding the interfaces at this time.
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