Model Number 595000-001 |
Device Problems
Device Inoperable (1663); Noise, Audible (3273)
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Patient Problems
No Patient Involvement (2645); No Information (3190)
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Event Date 09/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unusual noise during the freedom driver check in process.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.The customer-reported experience of squeaking and rattling could not be confirmed or reproduced during investigation testing.External and internal visual inspection of the driver revealed no abnormalities, and the driver passed all functional testing.An additional 48 hour extended observation run was performed and the driver performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
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Event Description
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The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unusual noise during the freedom driver check in process.
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Search Alerts/Recalls
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