Catalog Number 595000-001 |
Device Problems
Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)
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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 06/01/2017 |
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 the freedom driver 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, a syncardia certified hospital, reported that the freedom driver stopped for a few seconds and then restarted with an immediate fault alarm while supporting a patient.The customer also reported that the patient switched to the backup driver without any adverse impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed split housings.Visual inspection of the internal components of the driver revealed secondary motor out of bottom dead center (bdc) position and raised insert in bottom right housing boss.The alarm history was reviewed and revealed a fault code produced as a result of the primary motor pausing momentarily and the driver reverting to the secondary motor operation.The driver performed as intended during investigation testing with no evidence of a device malfunction.The customer-reported momentary stop and associated fault alarm could have occurred as a result of the bdc condition noted in the alarm history and visual inspection.The cause of the bdc condition could not be determined based on the information reported.However, it is possible the driver experienced an impact shock or rough handling that caused the motor position to move out of bdc.The evidence for rough handling was observed in visual inspection although it was not reported by the customer.The physical damage suggests that improper use was the root cause of the reported customer experience.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.Ce 3822 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 stopped for a few seconds and then restarted with an immediate fault alarm while supporting a patient.The customer also reported that the patient switched to the backup driver without any adverse impact.
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Search Alerts/Recalls
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