Catalog Number 595000-001 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2016 |
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 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 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.Review of the electronic data revealed a fault code of "bottom pressure too high" and a fault code of "bottom pressure too low" which are indicative of a potentially failing u22 pressure sensor on the main pcba (printed circuit board assembly) and is consistent with the alarm that the customer experienced.Further investigation of the main pcba confirmed that the root cause for the reported fault alarm was a malfunction of the pressure sensor (u22) on the main pcba.Syncardia has initiated a corrective action (capa) to address the issue of u22 pressure sensor failures.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with u22 pressure sensor failure events.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).
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Event Description
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The customer 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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