Section a: patient privacy laws in the event country prohibit the release of private patient information and initials and date of birth should have been removed from the previous report.Manufacturer's investigation conclusion: the reported event of the system controller surface being hotter than usual was not able to be determined.The system controller serial number (b)(6) was not available for evaluation.Per the additional information no product will be returned for analysis.A data log file provided by the customer was reviewed.The data log file contained events recorded from the time stamp of day 880, 22 hours and 57 minutes to day 889, 4 hours and 56 minutes where intermittent power cable disconnect and low voltage alarms were recorded.Some of these alarms appeared atypical; however, a specific root cause was not able to be determined.The recorded information revealed that the system maintained the set speed with no interruptions and the pump parameters appeared normal.The device history records were reviewed and the records revealed the controller was manufactured in accordance with manufacturing or qa specifications.Patient handbook, operating manual and instructions for use covers all alarms (visual and audible) on the system controller and what action should be performed when they do occur.The patient handbook advises the user to call the hospital contact person if there is any questions or concerns regarding the heartmate ii lvas equipment including the system controller.No further information was provided.The manufacturer is closing the file on this event.
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