Model Number 397002-001 |
Device Problems
Electrical /Electronic Property Problem (1198); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/15/2018 |
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 the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited an emergency battery error alarm.
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Manufacturer Narrative
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The customer-reported issue of an emergency battery alarm was confirmed during review of the alarm history data for the driver and reproduced during functional testing.The emergency battery was evaluated and found to have an unrecoverable permanent fault code of "4000," indicating that the emergency battery became severely depleted and was unable to recover.The likely root cause of the emergency battery error alarm was the depleted emergency battery due to intermittent shore power from either the hospital cart or caddy.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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