(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- (b)(4).The issue was observed at the (b)(4) depot.According to the service report# (b)(4) dated on (b)(4) 2018 following work has been performed: the rotalow console displayed head error when rpm is increased above 2500 rpm ans is non-functional.The service technician replaced the rf control board pcba kit (material# (b)(4), serial# (b)(4)).Preventive maintenance, functional test ans safety check as per the service manual have been performed.The rotaflow console passed all tests.Thus the failure could be confirmed.In the course of the investigation of (b)(4) all complaints were analyzed individually to look for patterns and causes.After evaluation of the complaints, the following defects are the most common: hot plug, sig error followed by head error, error message due to shaking / error message due to sensitivity, connection problems and hardware-error.The increase in complaints with the error "head error" is due to a user / application error.The actions have been addressed in the past to prevent application errors.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manual, (b)(4), contain detailed descriptions to prevent an "error head".In addition, the instruction manual describes how the user has to react in case of an error message so that the application can be continued if possible.Since there are several causes of errors that result in an error head (error head) message, no final root cause could be determined.It is noted that the evaluated error is largely due to a user error.Warning in the ifu regarding "hotplug" and label with the "hotplug" warning on the rfc have already been implemented in the past.
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