Model Number 397002-001 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce 5386; initial.
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Event Description
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The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver's emergency battery did not charge.
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Manufacturer Narrative
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During investigation testing, the reported issue was confirmed and reproduced.The emergency battery had an unrecoverable permanent fault; however, it could not be conclusively determined what caused the emergency battery to become permanently disabled.A permanently faulted emergency battery would not be able to hold a charge.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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