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 Patient Involvement (2645)
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Event Date 01/14/2019 |
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 the issue was observed when the companion external battery was not supporting a patient.The companion external battery will be returned to syncardia for evaluation.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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The companion external battery was not in patient use.The customer, a syncardia certified hospital, reported that the companion external battery would only hold a 20 minute charge.
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Manufacturer Narrative
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Visual inspection and system management (smbus) data review revealed no damage or abnormalities.The companion external battery passed all functional testing requirements including the required 30 minute discharge test.The battery performed as intended with no evidence of a device malfunction.Therefore, the root cause of the customer-reported early discharge could not be determined.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.Ce 4643 follow-up report 1.
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Search Alerts/Recalls
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