Model Number 0998-00-0800-53 |
Device Problem
Failure to Sense (1559)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/27/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Testing of actual/suspected device after further investigation, there was no issues with the ekg, and it was solely a user error.A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) had an ekg that could not be detected.No patient harm, serious injury or adverse event was reported.
|
|
Manufacturer Narrative
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) had an ekg that could not be detected.No patient harm, serious injury or adverse event was reported.Getinge field service engineer (fse) was confirmed that as per biomed eng the unit has no issues with the ekg.User error.
|
|
Event Description
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) had an ekg that could not be detected.There is patient involvement however no patient harm, serious injury or adverse event was reported.
|
|
Search Alerts/Recalls
|