Model Number 595000-001 |
Device Problems
Device Displays Incorrect Message (2591); Failure to Eject (4010)
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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 02/17/2018 |
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 fault alarm, the freedom driver continued to perform its life-sustaining functions.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) initial.
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm during an onboard battery exchange while supporting a patient.The customer also reported that the battery would not latch into place in the driver.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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The customer-reported issue of an onboard battery being stuck in the freedom driver was confirmed during visual inspection which observed a broken battery safety latch in the right battery well.The broken battery safety latch in the right battery well would not allow the removal of the left onboard battery, confirming the customer-reported issue.The root cause of the broken battery safety latch could not be determined from the information provided.Regardless of the broken battery safety latch, the driver passed all pressure test requirements associated with normotensive and hypertensive settings.Additionally, the onboard battery returned from the customer was evaluated and although revealed scratches, was fully functional and performed as intended in other drivers.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).
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Search Alerts/Recalls
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