Catalog Number 595000-001 |
Device Problems
No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/06/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
|
|
Event Description
|
The customer, a syncardia certified hospital, reported a non-clearing continuous fault alarm on freedom driver.Rn and respiratory therapist stating they had just suctioned patient, inducing a cough and patient started having a fault alarm that wouldn't clear.Patient changed to backup driver without incident.
|
|
Event Description
|
The customer, a syncardia certified hospital, reported a non-clearing continuous fault alarm on freedom driver.A nurse and a respiratory therapist reported that they had just suctioned patient, inducing a cough and patient's freedom driver started having a fault alarm that wouldn't clear.Patient was changed to backup driver without incident.
|
|
Manufacturer Narrative
|
Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history data review and visual inspection of internal components confirmed the customer reported fault alarm condition.Visual inspection of external components found no abnormalities.The freedom driver passed all functional testing at incoming inspection and during investigation testing.Complaint could not be replicated.The failure investigation found no evidence of a device malfunction.Patient was switched to a backup driver without any reported adverse impact.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4) follow-up report #1.
|
|
Search Alerts/Recalls
|