On june 26, 2020 fujifilm medical systems usa, inc.(fmsu) service department received a customer inquiry for assistance with synapse pacs powerjacket.When opening the powerjacket and selecting a patient off the worklist, the powerjacket displayed incorrect patient information.The doctor indicated that the issue occurred again when selecting another patient and the powerjacket again displayed a different patient.The fujifilm customer service representative did not identify any issues within the iis logs of the customer and the issue could not be reproduced.On july 08, 2020 a risk assessment was performed to investigate the risk to patient safety.There was no patient involvement, serious injury or death associated with this event.The issue is considered highly detectable by a healthcare professional; however this report is being submitted in abundance of caution.
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Updated information is provided in section h7, h9, and h10 (additional narrative).Fujifilm initiated a recall on 9/11/2020 to correct the powerjacket issue by providing a software upgrade to synapse pacs 5.7.200us.C&r report (1000513161-09/17/2020-001-c) was submitted to the fda.On 01/16/2021, the recall was classified by fda as class ii and assigned the recall number z-0878-2021.No further investigation is necessary.
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