Catalog Number 295025-001 |
Device Problems
Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/04/2017 |
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 the battery was in the battery charger and not in use in the patient's freedom driver at the time of the customer-reported issue.The freedom onboard battery 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 "prongs" on the bottom of the patient's freedom onboard battery pulled outward when removed from the battery charger.
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Manufacturer Narrative
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Physical inspection of the battery revealed it to exhibit connector / housing separation.In an attempt to reproduce the customer-reported condition (the 'prongs' on the bottom of freedom driver onboard battery pull outward when pulled out of the charger), the battery was installed and extracted three times in each bay of freedom battery charger returned with the battery.Following the installation / removal cycling of the battery, the battery terminals were examined and found to exhibit connector / housing separation, thereby duplicating and confirming the customer-reported issue.The root cause for the connector / housing separation is likely the result of a high number of insertion / extraction cycles the battery had accumulated during use in the field.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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Search Alerts/Recalls
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