Model Number 397002-001 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
malfunction
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Event Description
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Received a call from uab that when attempting to connect non-clinical c2 drivelines to drivline connection, there was great difficulty in making the connection and they were uncomfortable using this driver as a backup for their current patient.
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Event Description
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Received a call from uab that when attempting to connect non-clinical c2 drivelines to driveline connection, there was great difficulty in making the connection and they were uncomfortable using this driver as a backup for their current patient.
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Manufacturer Narrative
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Device history record (dhr) review confirmed that companion 2 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.Driver passed all sections of functional testing for acceptance at incoming inspection.A series of driveline connections were also performed with a variety of drivelines without issue or any malfunction.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint could not be replicated; root cause of the driveline connection issues could not be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.There was no evidence of a device malfunction 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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Search Alerts/Recalls
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