Catalog Number 293001-001 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/21/2019 |
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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The battery was dispositioned to scrap before the investigation had begun, therefore, no investigation into the reported event could be conducted.Syncardia is closing this file.Ce (b)(4) follow-up report 1.
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Search Alerts/Recalls
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