Model 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 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) initial.
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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 adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed extensive damage including a displaced spring on the driveline cpc connector, a broken top left housing boss, bent leads on the u22 pressure sensor on the main printed circuit board assembly (pcba) and scuff marks on the main pcba and primary motor.All of the observed damage indicates that the driver was likely subjected to rough handling or an impact shock.Despite the visual damage observed, the driver passed all incoming functional test requirements on both the primary and secondary motor circuits.The customer-reported fault alarm was confirmed by the alarm codes recorded in the driver's alarm history.A fault alarm during investigation testing was only reproduced by the forced engagement of the secondary motor.The likely cause for the fault alarm experienced by the customer was the driver having been subjected to an impact shock or jolt, causing the driver to switch from operating on the primary motor to operating on the secondary motor.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) 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 adverse patient impact.
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Search Alerts/Recalls
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