Manufacturer's investigation conclusion: the reported event of damage to the black power cable of the system controller was confirmed via the submitted picture; however, the reported event of power cable disconnect alarms was not confirmed.There was no log file submitted for review.System controller, serial (b)(6), was not returned for analysis.The provided information indicated that there was damage to the black power cable of the controller with associated power cable disconnect alarms.The submitted picture displays a bent pin 3.This pin is a redundant negative voltage pin.The root cause for the reported alarm is consistent with a bent pin in the black connector; however, the root cause of the damage was not conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The patient handbook 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.Heartmate 3 instructions for use (ifu) section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to troubleshoot power cable alarms.Heartmate 3 instructions for use section 8-¿equipment storage and care¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly take care and maintain the integrity of the system controller.The ifu states in the ¿guideline for power cable connectors¿ section to ¿line up the half circles inside the connectors¿ gently bring the connectors together, turning them slightly to make the connection, if needed.Never twist connectors or pull them apart at an angle.¿ no further information was provided.The manufacturer is closing the file on this event.
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