Model Number 397002-001 |
Device Problem
Noise, Audible (3273)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/15/2017 |
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 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 unusual noise during a training session.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.The reported noise emanating from the driver was confirmed and reproduced during investigation testing.The root cause was determined to be a malfunction of the right compressor.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.(b)(4) follow-up report 1.
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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 unusual noise during a training session.
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Search Alerts/Recalls
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