|
Model Number N/A |
Device Problem
Connection Problem (2900)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/13/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
A getinge field service engineer (fse) evaluated the iabp unit and attempted to fix the reported issue by replacing the ecg port.However, the fse determined that the unit needed a new ecg cable instead.To fix the reported issue, the fse sold the customer an ecg cable from trunk stock and the unit began to work properly with the new ecg cable.The fse then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
|
|
Event Description
|
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unit had a faulty ekg connection.After further evaluation, it was reported that the defective cable caused a communication error.No patient harm, serious injury or adverse event was reported.
|
|
Event Description
|
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unit had a faulty ekg connection.After further evaluation, it was reported that the defective cable caused a communication error.No patient harm, serious injury or adverse event was reported.
|
|
Search Alerts/Recalls
|
|
|