The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm and the beat rate dropped by 4 bpm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.
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Visual inspection revealed the secondary motor cam follower 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 customer-reported alarm and 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.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 tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.B)(4) follow-up report 1.
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