Model Number 595000-001 |
Device Problems
No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce (b)(4).
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Event Description
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The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a fault alarm during an onboard battery exchange while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently changed to a backup driver.
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Manufacturer Narrative
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The driver's alarm history was reviewed and revealed a "39" alarm code which can be produced during power cycling of the freedom driver, during an onboard battery exchange while operating freedom driver only on onboard battery power, or if an onboard battery is not fully latched in place; intermittent communication errors can result in this fault alarm.The driver passed all sections of functional testing.Additionally, an onboard battery exchange test was performed in an attempt to replicated the customer-reported issue.Known functioning freedom onboard batteries were inserted and removed alternately in the driver's battery wells several times.No alarms were produced during this test.The freedom onboard batteries used at the time of the reported issue were not returned and therefore could not be included as part of this investigation.The root cause of the customer-reported driver fault alarm after an onboard battery exchange could not be conclusively determined.The batteries used by the patient at the time of the reported event were not returned for evaluation.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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Search Alerts/Recalls
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