Catalog Number 595000-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
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.
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Event Description
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The customer, a syncardia authorized distributor, reported the patient was resting at home and experienced a fault alarm on the driver.The patient was switched to a back-up driver.
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Manufacturer Narrative
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Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found one new alarm recorded in the driver's data file; time-out alarm.Time-out code typically produced by non-engagement of the primary motor.Visual inspection of external components found no abnormalities.Visual inspection of internal components found no abnormalities.Freedom driver passed all functional testing for acceptance at incoming inspection.Additional testing was performed via 120 hour observation run.No significant changes in value were observed, no alarms produced, and no evidence of device malfunction.Customer complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The complaint was not replicated during testing; the root cause of the noise, sudden value change, and red alarm was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.Freedom driver functioned as designed.Patient was switched to a backup driver without any reported adverse impact.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.
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Event Description
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The customer, a syncardia authorized distributor, reported the patient was resting at home and experienced a fault alarm on the driver.The patient was switched to a back-up driver.
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Search Alerts/Recalls
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