Model Number 595000-001 |
Device Problems
Patient-Device Incompatibility (2682); Noise, Audible (3273)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2018 |
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 will be 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 hospital standby freedom driver was turned on in preparation for a patient driver switch and the patient didn't not like the sound of the driver.The customer also reported that the freedom driver passed the system checkout.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed no abnormalities.During investigation testing, the driver did not exhibit any unusual sounds or alarms.The driver performed as intended with no evidence of a device malfunction.The customer-reported experience of freedom driver noise could not be reproduced or verified.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 hospital standby freedom driver was turned on in preparation for a patient driver switch and the patient did not like the sound of the driver.The customer also reported that the freedom driver passed the system checkout.
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Search Alerts/Recalls
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