Catalog Number 295025-001 |
Device Problems
Failure to Charge (1085); Battery Problem (2885)
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Patient Problems
No Patient Involvement (2645); No Information (3190)
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Event Date 04/12/2018 |
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 the issue was observed when the battery was not supporting a patient.Also, patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.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).
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Event Description
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The customer, a syncardia certified hospital, reported that the freedom onboard battery would not hold a charge.
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Manufacturer Narrative
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Visual inspection revealed housing weld separation at the gas gauge and adjacent black scuff / impact marks.Initial system management (smbus) data review revealed the battery to be permanently disabled.The root cause for the customer-reported issue of failing to hold a charge was likely the physical impact the battery sustained as evidenced by the marring, scratches and housing weld separation.Syncardia has a corrective and preventive (capa) to address permanently faulted freedom onboard batteries.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4273 follow-up report 1.
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Search Alerts/Recalls
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