Section d4: serial number was requested but not provided.Section d6a: implant date inadvertently reported in previous report and is not applicable for this device.Manufacturer's investigation conclusion: the reported event of no external power alarm was confirmed via the log file review.The log file spanned approximately 18 days (06may2021 to 24may2021 per the timestamp).A no external power alarm was observed on 19may2021 at 19:31 due to rsoc and bus voltage diminishing to ~0v while the device was connected to mobile power unit.The backup battery was able to provide power to the pump during the alarm.The alarm resolved shortly after reconnecting to a power source.No other notable alarm was observed.The mobile power unit was not returned for analysis.Multiple attempts were made to obtain additional information regarding the event; however, no response was received.A root cause of the reported event was determined to be power outage at the patient¿s house.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate iii instructions for use (rev.A) section 7-¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.C) section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including no external power.No further information was provided.The manufacturer is closing the file on this event.
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