Manufacturer's investigation conclusion: the reported event of atypical power cable disconnect and low voltage alarms was confirmed via the log file submitted for review.However, the investigation could not confirm the damage to the power cables, as there were no images submitted to this complaint.A review of the submitted log file contained 240 events spanning approximately 9+ days ((b)(6) 2022 per timestamp).The controller recorded intermittent atypical power cable disconnect events that were not associated with a power source exchange and were due to power cable faults occurring on both power cables when the system controller was connected to battery power.These events accompany the power cable disconnect alarm.Low voltage advisory alarms were also recorded and caused by normal battery depletion.Pump operation was not affected and maintained speeds above the lsl throughout the log file.The system controller pcx-19120 was not returned for analysis, as it was discarded.Due to the controller being unavailable for analysis, the complaint file will be closed without further action.The exact cause for the atypical events captured in the log file and the reported damage to the controller power cables was not determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(4) and was found to pass all manufacturing and quality assurance specifications before being shipped to the customer on 30jun2020.Heartmate ii instructions for use (ifu) section 2 entitled ¿system operations¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.No further information was provided.The manufacturer is closing the file on this event.
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