Model Number 595000-001 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2020 |
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.(b)(4) initial.
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom driver connection 1 receptacle was damaged while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.
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Manufacturer Narrative
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The customer-reported broken connection to the power adaptor was confirmed via visual inspection where it was observed that the connection (b)(4) receptacle cable retaining clip was broken.This is the connection point between the power adaptor and the driver.The cable could no longer attach to the driver housing.It cannot be conclusively confirmed how the connection (b)(4) receptacle cable retention clip was damaged, but it is most likely the result of either the application of excessive force when connecting the power adaptor to the driver, or rough handling/an impact shock to the driver.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report (b)(4).
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Search Alerts/Recalls
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