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 10/22/2019 |
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 passed all functional procedures.The battery performed as intended with no evidence of a device malfunction.The reason for the battery initially failing the evaluation procedure is most likely due to the tolerance window of the voltage that the battery is allowed to be charged at (currently 16.4 v±0.1v).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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