It was reported to siemens on (b)(6) 2018 that a malfunction occurred while operating the somatom force system.The customer had been made aware of the voluntary correction and removal action which was initiated and notified to the fda on (b)(6) 2017, with report id # 2240869-04/05/17-0012-c.The addendum to the instructions for use of the somatom force system, with software version va50a is related to the use of the turbo flash mode with very short scan ranges.The addendum informs the customer that when selecting the turbo flash mode in combination with a spiral scan length of less than or equal to 27 mm, the image reconstruction will possibly fail for this scan.The workaround suggested in the addendum is to always select a spiral scan length of more than 27 mm or to switch to another mode instead.The operator in this incident selected a 27 mm range, and the reconstruction of the ct pictures failed, causing the system malfunction.The operator confirmed that he was aware of this addendum, but unfortunately during the procedure with a (b)(6) infant male patient, the operator mixed up the minimum scan range, and the newborn patient got a repeat examination with an additional x-ray dose.According to available information, there was no further negative impact to the newborn patient.This event occurred in the united states.
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