The reported event of the monitor rebooting was confirmed.The centrimag monitor (serial #: (b)(4) was returned for analysis to the service depot.The monitor was connected to a test loop and while operating, the monitor was observed to occasionally reboot.It was noticed that this behavior would only happen when connected to the right-hand side connector of the monitor and not on the left-hand side of the connector.The monitor main printed circuit board (pcb) was replaced, resolving the issue.The monitor was then run on a test loop for several days and no issues occurred on either monitor port during observation.The monitor was functionally tested and operated as intended.The replaced pcb was forwarded to product performance engineering (ppe) for further analysis.Upon further analysis with ppe, the main pcb was in unremarkable condition.The left and right hand side connectors were tested individually; however, the rebooting was unable to be reproduced again during observation.The root cause of the reported event was unable to be conclusively determined through this analysis; however, the issue was isolated to the main pcb of the unit.Incidental findings: main pcb damage.The device history records were reviewed for the centrimag monitor (serial #: (b)(4) and the monitor was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual] section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the manufacturer is closing the file on this event.
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