Based on the logfile analysis, the case in question could be reconstructed and it was found that a used-up battery has caused the reported shutdown.The case in question was started at 8:24am.At 9:07am, the device alarmed for battery low.At 9:09am, the device switched to man/spont-mode and alarmed ventilator fail accordingly.The case in question was continued in this mode for 15 minutes and then switched to standby mode at 9:23am.The last log file entry was logged at 9:24am when the device switched off based on a discharged battery set.In case of a power failure, the primus device switches to battery mode automatically.As described in the ifu, the message power fail is displayed on the screen together with the remaining battery capacity in percent.If the battery is almost empty, the message battery low will be given, as it could also be confirmed for the case in question.In the event of a power failure and empty batteries, the primus permits manual ventilation with 100 % o2.The ifu further describes to check the vaporizer settings and to press the safety knob for o2 emergency delivery and to set it to the required o2 flow, this o2 flows through the vaporizer.The batteries are subject to an aging process and are replaced periodically during product maintenance (each 3 years).For further analysis, the battery was requested but was unfortunately not available.Pictures of the battery-set were provided showing the prints on the battery-set.Those showed that the battery was produced in 2020-04-19.The recommended shelf life of the battery set is 180 days.A label on the package of the battery-set shows the production- as well as used-by date.Dräger finally concludes that the excess of maximum storage time leading to already pre-damaged batteries when being installed was the root cause of the shutdown during use.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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This is a correction of the previous report.The model no.Was corrected.As the affected primus, serial no.(b)(6) , was manufactured in january 2011, a unique device identifier (udi) is not required.
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