This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Other devices involved in this event: heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-08-31.Udi #: (b)(4).Return date: 2018-05-22.Device evaluation anticipated, but not yet begun.Mfg date: 2017-08-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-08-31.Udi #: (b)(4).Return date: 2018-05-22.Device evaluation anticipated, but not yet begun.Mfg date: 2017-08-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30.Udi #: (b)(4).Return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2017-09-30.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30.Udi #: (b)(4).Return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2017-09-30.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30.Udi #: (b)(4).Return date: 2018-05-22.Device evaluation anticipated, but not yet begun.Mfg date: 2017-09-30.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30.Udi #: (b)(4).Return date: 2018-05-22.Device evaluation anticipated, but not yet begun.Mfg date: 2017-09-30.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30.Udi #: (b)(4).Return date: 2018-05-22.Device evaluation anticipated, but not yet begun.Mfg date: 2017-09-30.(b)(4).Heartware ventricular assist system ¿ battery.Controller ac adapter / (b)(4) / model #: 1430us / expiration date: unknown.Udi #: (b)(4).Return date: 2018-05-24.Device evaluation anticipated, but not yet begun.Mfg date: 2017-05-17.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30.Udi #: (b)(4).Return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2017-09-30.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Product event summary: one controller, eight batteries, and one controller ac adapter were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the controller, batteries, and controller ac adapter revealed that the devices passed visual examination and functional testing.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log files revealed several premature power switching events that were due to momentary disconnections involving the batteries.Log file analysis also revealed one controller power up event, with an associated motor start, on (b)(6) 2018 at 18:19:18.The data point prior to the controller power up, logged at 18:15:42, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2; both batteries had experienced a momentary disconnection within the preceding 15 minutes.The data point after the controller power up event, logged at 18:19:55, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2.The controller was without power for 15 seconds.As a result, the reported power switching, and loss of power events were confirmed.The most likely root cause of the reported power switching event can be attributed to momentary disconnections between the controller and batteries.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 or both power sources.(b)(4) internal investigations were initiated to capture events involving the controller losing power and momentary disconnections.Additional products: battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 controller ac adapter / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 battery / (b)(4) h3: yes h6 fda method code(s): 10, 4112 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12.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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