Model Number 595000-001 |
Device Problems
Device Displays Incorrect Message (2591); Audible Prompt/Feedback Problem (4020)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/30/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited intermittent fault alarms, 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).
|
|
Event Description
|
The customer, a syncardia certified hospital, reported that the freedom driver exhibited intermittent fault alarms when the patient moved around the hospital room and changed positions in bed.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.
|
|
Manufacturer Narrative
|
The customer-reported alarms and decreased fill volumes could not be confirmed or reproduced during investigation testing.Visual inspection of the driver revealed no abnormalities, and the driver passed all functional testing.Additionally, extended observation testing and manipulation of the drivelines were not able to identify any abnormalities or unexpected alarms from the driver.The driver performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
|
|
Search Alerts/Recalls
|