Catalog 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 08/12/2022 |
Event Type
malfunction
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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 while the patient was resting at home.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 freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
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Manufacturer Narrative
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Alarm history data review found one new permanent alarm recorded in the alarm history; this alarm can occur as a result of driver testing of the secondary motor or secondary motor engagement in the field.Visual inspection found no evidence of secondary motor engagement.Visual inspection found no evidence of damage to external or internal driver components.The driver underwent an extended observation test with no issues or alarms observed.The root cause of the customer-reported issue could not be determined.Investigation could not confirm or replicate the customer reported fault alarm.The investigation found no evidence of a device malfunction.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).Follow-up report 1.
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Search Alerts/Recalls
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