Model Number 595000-001 |
Device Problems
Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a temperature alarm, it continued to perform its life-sustaining functions.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 customer, a syncardia certified hospital, reported that the freedom driver exhibited repeated temperature alarms while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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Visual investigation revealed split housings, a damaged exhaust fan and pulled bosses.The customer-reported issue of repeated temperature alarms was confirmed during investigation testing and the root cause was determined to be non-operational exhaust fan.The root cause of the exhaust fan failure is likely to be misuse or rough handling as evidenced by the damage noted in the visual inspection.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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