Model Number 0998-00-0800-33 |
Device Problem
Output Problem (3005)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/21/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed power up test failure code #6.There was no patient involvement reported.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Manufacturer Narrative
|
Corrected data: b5 updated data.
|
|
Event Description
|
It was reported that during routine checkup, the cardiosave intra-aortic balloon pump (iabp) displayed power up test failure code #6.There was no patient involvement reported.
|
|
Manufacturer Narrative
|
A getinge field service engineer (fse) evaluated the unit for the reported malfunction.The fse calibrated the touch screen.Functionality was checked and found to be okay.Functionality checks were performed and all tests passed.The iabp was handed over to the customer in working condition.
|
|
Search Alerts/Recalls
|