Section d6a: implant date was inadvertently provided in previous report.Implant date is not applicable for heartmate mobile power unit.Manufacturer's investigation conclusion: the reported event of the mpu not working was confirmed.The mobile power unit, serial number (b)(6) , was received and evaluated at the service depot where is was confirmed that the unit would not power on.Further evaluation confirmed damaged components on the power supply pcb (printed circuit board).As a result the mpu was not able to provide power.A specific root cause for the damaged components was not able to be determined.The power supply and the patient cable were replaced.The mpu was functionally tested and passed all test steps.The device history records were reviewed and the records revealed the mpu was manufactured in accordance with manufacturing and quality assurance specifications.Heartmate 3 patient handbook, under section ¿alarms and troubleshooting¿ explains all alarms and the proper actions to take if the alarms cannot be resolved.The patient handbook, also 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.No further information was provided.The manufacturer is closing the file on this event.
|