Model Number 397002-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/20/2019 |
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 2 driver was not supporting a patient.The companion 2 driver is being 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 2 driver exhibited an emergency battery error alarm.
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Manufacturer Narrative
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The reported emergency battery error alarm was confirmed during review of the patient file review.During the battery evaluation, a cell under voltage safety flag (cuv) and a pack under voltage safety flag (puv) were observed.These firmware safety flags indicated that the battery cells went below the allowed voltage level which occurs during a "full-discharge" event.The root cause of the reported alarm was a depletion of the emergency battery during an undercharge event which resulted in an unrecoverable permanent fault.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.Ce 5089 follow-up report 1.
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Search Alerts/Recalls
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