Model Number 595000-001 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/22/2016 |
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 although the freedom driver exhibited a fault alarm, it continued to perform its life-sustaining functions.The freedom driver has been 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 freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.Investigation testing determined the root cause of the customer-reported fault alarm was a degraded pressure sensor (u22) on the main printed circuit board assembly (pcba).Syncardia has an open corrective and preventive action (capa) to address this issue with the u22 pressure sensor and is currently in the effectiveness verification stage.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 freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.
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Search Alerts/Recalls
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