Model Number 595000-001 |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
malfunction
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Event Description
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While performing routine servicing, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.
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Manufacturer Narrative
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The freedom driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4).
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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, indicating secondary motor voltage was too high, recorded in driver's data file.Visual inspection of external components found the freedom adaptor alternate connector cover torn and rear housing mounting rail retention clip broken off.Visual inspection of internal components found bottom left anchor boss on front housing damaged.As there was no indication of secondary motor engagement, it was likely that the alarm was produced during data file extraction.Freedom driver failed functional testing for out of specification left atrial pressure.Additional testing included installing a known functional piston cylinder assembly to replace the existing pca.Driver passed all areas of functional testing with replacement pca.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; root cause of out of specification lap was determined to be a faulty piston cylinder assembly.Failure investigation identified no other test failures or damage that could have contributed to complaint.The external and internal damage found was cosmetic only and considered normal wear and tear.Driver was not in patient use at time of complaint.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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While performing routine servicing, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.
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Search Alerts/Recalls
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