Section b5: the backup battery fault alarm on 14dec2021 and no external power event on 23jan2022 were deemed non-reportable and inadvertently included in the previous report.This report was intended to capture the 24jan2022 system controller exchange due to atypical power cable disconnects and suspected power cable damage.Manufacturer's investigation conclusion: the reported events of power cable disconnect and no external power alarms was confirmed via the provided log file.The log file contained data spanning approximately 46 days (09dec2021 ¿ 24jan2022 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.A few atypical power cable disconnect alarms (alarms not associated with a power source exchange) were intermittently observed throughout the data, and each alarm appeared to have resolved within the next recorded event.A no external power alarm was also observed on 23jan2022 at 4:49.The alarm appeared to have been caused by disconnections of both power cables, and the alarm resolved within the next recorded event when power was restored to the system.No other notable events were observed.The returned system controller (serial number (b)(6) was functionally tested and operated a mock loop as intended throughout all testing.Atypical alarms were unable to be reproduced, even when the controller¿s power cables were manipulated by hand.The root cause of the reported power cable disconnect alarms was unable to be conclusively determined.The root cause of the observed no external power alarm appeared to have been disconnections of both power cables from external power.During the investigation wire fatigue was observed within controller¿s black power cable.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate ii patient handbook (rev.F, section 2 ¿how your heart pump works¿) instructs users that the 11-volt backup battery should only be used as temporary support in a power loss emergency.Inappropriate use of the backup battery may result in diminished runtime during a power loss emergency.The heartmate ii patient handbook (rev.F, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s power cords, and to obtain replacements if needed.The heartmate ii patient handbook (rev.F, section 5 ¿alarms and troubleshooting¿) describes all alarms (visual and audible) and what action should be performed when they do occur, including alarms associated with power cable disconnect and no external power alarm conditions: to resolve the no external power alarm: 1.Immediately connect the system controller power cables to a working power source (functioning mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.Call your hospital contact immediately if connecting to power does not resolve the alarm.The heartmate ii patient handbook (rev.F, section titled ¿emergency contact list¿) cautions 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.No further information was provided.The manufacturer is closing the file on this event.
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