Model Number 595000-001 |
Device Problems
Mechanical Problem (1384); Positioning Problem (3009)
|
Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/07/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.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 freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that a freedom onboard battery could not be removed from the freedom driver.
|
|
Manufacturer Narrative
|
The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver found damage to the left and right battery wells, including a broken battery safety latch in the right battery well.Internal inspection also identified scuff marks on the primary motor and main printed circuit board (pcb), along with a fractured housing boss.The customer-reported onboard battery stuck in the left battery well of the freedom driver was confirmed.The broken right safety battery latch did not allow the left onboard battery to be removed by hand from the driver.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.
|
|
Event Description
|
The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that a freedom onboard battery could not be removed from the freedom driver.
|
|
Search Alerts/Recalls
|