Model Number 397002-001 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 12/07/2018 |
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 supplier, a syncardia authorized warehouse, reported that the companion 2 driver did not charge its emergency battery despite being plugged in for several days.
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Manufacturer Narrative
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The customer-reported issue of the emergency battery not charging was confirmed during review of the driver alarm history and reproduced during functional testing.The emergency battery was evaluated and found to have an unrecoverable permanent fault code of 4000.This fault code indicates the emergency battery was discharged beyond the point it could be recharged.The likely cause of the depleted emergency battery was intermittent shore power from either the hospital cart or caddy.No other equipment was returned; therefore, no further investigation could be performed.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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