Catalog Number 293001-001 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because although one external battery drained at a faster rate than the other external battery, the companion 2 driver continued to perform its life-sustaining functions.Also, the companion 2 driver has a redundant, alternate power source of external wall power.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
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Event Description
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The customer, a syncardia certified hospital, reported that one of the companion external batteries does not discharge at the same rate as the other external battery in the companion 2 driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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The customer-reported issue of the battery discharging too quickly was confirmed during investigational testing.The battery was unable to meet the minimum discharge duration of 30 minutes.The root cause was determined to be a damaged cell.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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