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 10/30/2019 |
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 was determined to be the pack under voltage (puv) protection circuit cutting output current from the battery before the cells were actually at risk of being depleted.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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