Model Number 397002-001 |
Device Problems
Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2017 |
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 it did not prevent the companion 2 driver from performing its life-sustaining functions.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 customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue of the driver's compressor cycling on and off was confirmed.Investigation testing determined the root cause to be a malfunction of the manual pressure regulator.Syncardia has a corrective and preventive action (capa) to address the issue of compressor cycling.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 customer, a syncardia certified hospital, reported that the companion 2 driver compressors cycled on and off while the driver was connected to wall air and supporting a patient.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
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Search Alerts/Recalls
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