Model Number 397002-001 |
Device Problems
Noise, Audible (3273); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses low risk to the patient because the reported issue did not prevent the driver from performing its life sustaining functions.The companion 2 driver 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 customer, a syncardia certified hospital, reported that the companion 2 driver compressor was making a strange noise while on wall pressure and exhibited a compressor malfunction alarm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup companion 2 driver.
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Manufacturer Narrative
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The customer-reported issue of the compressors making noise while on wall air was confirmed via investigation testing.The root cause was determined to be a malfunction of the manual pressure regulator, which was unable to maintain the required pressure set point value.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 5045 follow-up report 1.
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Search Alerts/Recalls
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