Catalog Number 293001-001 |
Device Problem
Battery Problem (2885)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2019 |
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 companion external battery was not supporting a patient.The companion external battery will be evaluated by syncardia.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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While performing a routine evaluation, a syncardia technician reported that the companion external battery discharge time was outside the testing acceptance criteria.
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Manufacturer Narrative
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During investigation testing, the battery issue was replicated as the discharge time was outside the testing acceptance criteria.The root cause of the battery not passing the evaluation procedure is likely due to the battery losing capacity over time.This is the result of regular degradation.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.Ce (b)(4) follow-up report 1.
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Search Alerts/Recalls
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