Catalog Number 397002-001 |
Device Problems
Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
|
Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/13/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.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).
|
|
Event Description
|
The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver did not pass the system checkout.
|
|
Manufacturer Narrative
|
The companion 2 driver was returned to syncardia for evaluation.Review of the patient file revealed the occurrence of two system check failures, thus confirming the reported customer experience.The customer-reported system check failures were reproduced during failure investigation testing.Analysis of the test results identified a malfunction of the pressure sensor printed circuit assembly (pca) as the root cause of the reported issue.The investigation determined that right driveline pressures could not be accurately measured because of the pressure sensor pca malfunction.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).
|
|
Event Description
|
The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver did not pass the system checkout.
|
|
Search Alerts/Recalls
|