The pba therapy control unit incl.Cf (compact flash) card was available for investigation.The components were tested in a lab device for three days without finding any deviations.Based on the log analysis the case in question was analyzed.It was found that due to a faulty cf card the device performed a reboot.The cf card failure was repaired by an automatic formatting triggered by the device.If the pba therapy control unit no longer can access the cf card the device performs a reboot.The therapy is discontinued for a maximum of 15 seconds, before therapy will be resumed with the last valid settings.If the reboot is not successful an acoustical alarm will be given and a "system failure" message is posted.Manual ventilation remains possible.Finally, the reported symptom is comprehensible and can be traced back to a faulty cf card.As due to the cf card failure relevant log entries were not recorded a detailed statement regarding given alarms is not possible.Reportedly, the device alarmed for a ¿cf card failure¿.Besides this, it can be assumed that also "loss of data", "therapy settings not applied" and "system failure" alarms were given.The pba therapy control unit inclusive cf were replaced and the device was returned to 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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