Catalog Number P/N 595000-001 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom driver will be evaluated at syncardia.The results will be provided in a follow-up mdr.
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Event Description
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During routine evaluation, a syncardia service technician reported the driver failed incoming testing.
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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 no new alarms.Visual inspection of external and internal components found no abnormalities.Freedom driver failed incoming inspection for temporary alarms and asterisks on display.Driver passed all areas of functional testing during inspection for investigation.Additionally, a peak pressure was performed to mimic fluctuating fill volumes and cardiac output, however, complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue.The customer complaint was not replicated; root cause of display issue could not be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.No evidence of a design malfunction was found.Device 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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During routine evaluation, a syncardia service technician reported the driver failed incoming testing.
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Search Alerts/Recalls
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