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 11/03/2020 |
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.(b)(4); initial.
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Event Description
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The customer at a syncardia certified hospital, reported that when the patient was ambulating, the freedom driver exhibited intermittent fault alarms.The alarms resolved when the patient was back in bed.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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Manufacturer Narrative
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The customer-reported intermittent and/or temperature alarms were unable to be confirmed or replicated.Temperature alarms are not recorded in the driver's alarm history unless they persist for at least 30 minutes.Review of the driver's alarm history did not reveal any alarm codes.The freedom driver passed all functional testing; including a 48-hour observation test with no abnormalities or recorded alarms.The root cause of the customer-reported issue could not be conclusively determined.The freedom 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.Ce 5408 comp-2022-0056 follow-up report 1.
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Search Alerts/Recalls
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