Manufacturer's investigation conclusion: the reported event of a battery alarm was not confirmed.The centrimag 1st generation primary console (serial #: (b)(4)) was not returned for analysis.Additional provided information communicated on 15feb2021 stated that the console battery was depleted, and the system will not charge the battery due to an issue with the charging printed circuit board (pcb); however, the console will not be returned for analysis.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag 1st generation primary console (serial #: (b)(4)) and the console was found to pass all manufacturing and quality assurance specifications.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction." no further information was provided.The manufacturer is closing the file on this event.
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