The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unrecoverable fault alarm after the patient coughed.There was no reported adverse patient impact.The customer also reported the patient was subsequently switched to a backup driver.
|
Visual inspection of the exterior of the driver showed no signs of damage.Visual inspection of the interior revealed the driver's secondary motor to be out of bottom dead center (bdc) position.The driver's alarm history was reviewed and revealed a '2d' fault alarm code.This alarm is produced as a result of the operation of the secondary motor.Since the secondary motor was observed to be out of the bdc position, it is likely that this is the reported alarm and it was produced because of secondary motor engagement.The conditions that caused the secondary motor cam follower to move out the bdc position cannot be conclusively determined, but it is possible that it occurred due to a drop, near drop, or other rough handling of the driver.It could have also been caused by a jolt to the driver during the patient's coughing episode.Despite the observed secondary motor cam follower moved out of bdc position, functional testing confirmed that the driver functioned as intended on both the primary and secondary motor circuits.The driver performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
|