Model Number 595000-001 |
Device Problem
Output Problem (3005)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/18/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the freedom driver from performing 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).
|
|
Event Description
|
The customer, a syncardia certified hospital, reported that the freedom driver exhibited unstable fill volumes and the motor was making an unusual sound while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.
|
|
Manufacturer Narrative
|
The driver in "as received" condition passed all sections of functional testing.Additionally, an extended observation run was performed on the driver and no unusual sounds or fluctuating fill volumes were observed.During investigation testing, the customer-reported unstable fill volumes and unusual sound were not able to be confirmed or reproduced.The driver performed as intended with no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.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.
|
|
Search Alerts/Recalls
|