Model Number 397002-001 |
Device Problem
Device Displays Incorrect Message (2591)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/25/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a left pressure incorrect alarm, it continued to perform its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4) initial.
|
|
Event Description
|
The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a left pressure incorrect alarm while supporting a patient.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
|
|
Manufacturer Narrative
|
The electronic patient data were reviewed and confirmed the customer-reported issue.During investigation testing, the left pressure incorrect alarms were reproduced and the root cause was determined to be a malfunction of the left electronic pressure regulator.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
|
|
Search Alerts/Recalls
|