It was reported that, during a battery exchange, the ventricular assist device (vad) controller experienced a loss of power, the "system controller triangle turned red, (the) screen went blank and no audible alarms came on." the controller was exchanged.No patient complications have been reported as a result of this event.
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Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis revealed that the returned controller passed visual inspection and functional testing; the controller was able to alarm appropriately.As a result the "no audible alarm" event could not be confirmed.Log file analysis revealed a controller power up event on (b)(6) 2018 at 18:03:05.The data point prior to the loss of power revealed that a battery was connected to power port one (1) with 60% relative state of charge (rsoc) and a battery was connected to power port two (2) with 24% rsoc.The data point recorded after the loss of power revealed that a battery was connected to power port (1) and no power source was connected to power port two (2).The controller was without power for 14 seconds.During a loss of power event, the controller screen will be blank, and upon controller start up, the alarm indicator on the controller's front panel will flash red for a brief moment.As a result, the reported "loss of power, alarm indicator turned red and screen went blank" events were confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one power source.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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