Catalog Number 295025-001 |
Device Problems
Failure to Charge (1085); Charging Problem (2892)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/12/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The customer reported that the patient's two freedom onboard batteries were not maintaining a charge.The medical device report for freedom onboard battery s/n (b)(4) is #3003761017-2016-00158.The customer also reported that the patient was provided with replacement onboard batteries.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external wall power.The freedom onboard batteries will be evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.
|
|
Manufacturer Narrative
|
The freedom onboard battery was returned to syncardia for evaluation.Visual inspection of freedom onboard battery s/n (b)(4) revealed no physical abnormalities.The system management bus (smbus) data was reviewed and revealed no anomalies and all values were within specification.The onboard battery in "as received" condition passed all functional testing including discharge testing.The onboard battery performed as intended and there was 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 of this complaint and is closing this file.(b)(4) follow-up report 1 (2 of 2).
|
|
Event Description
|
The customer reported that the patient's two freedom onboard batteries were not maintaining a charge.The medical device report for freedom onboard battery s/n (b)(4) is #3003761017-2016-00158.The customer also reported that the patient was provided with replacement onboard batteries.There was no reported adverse patient impact.
|
|
Search Alerts/Recalls
|