Catalog Number 595000-001 |
Device Problems
Difficult to Remove (1528); Sticking (1597)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/22/2016 |
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.In addition, it would not prevent the driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external power.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 customer reported that during a training/demonstration, the freedom onboard battery became stuck in the battery well of the freedom driver.The customer also reported that she was unable to remove the onboard battery after confirming that the dummy onboard battery was in place.She continued to try to remove the onboard battery but was unsuccessful after multiple attempts.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed damaged housing.Visual inspection of the internal components of the driver revealed a broken battery safety latch in the right battery well.This is the likely cause of the onboard battery extraction customer-reported issue.With a broken battery safety latch in the right well, an onboard battery in the left well would not be able to be removed.It cannot be conclusively determined how the battery safety latch in the right battery well became damaged, although the damage noted on the driver housing indicates rough handling (improper use), which is the most likely root cause of the customer-reported issue.The onboard battery returned with the driver passed a fit check when performed with a clinical driver and met all dimensional tolerances on the released version of the drawing.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 customer reported that during a training/demonstration, the freedom onboard battery became stuck in the battery well of the freedom driver.The customer also reported that she was unable to remove the onboard battery after confirming that the dummy onboard battery was in place.She continued to try to remove the onboard battery but was unsuccessful after multiple attempts.
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Search Alerts/Recalls
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