DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-3023-53 |
Device Problems
Electrical /Electronic Property Problem (1198); Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/09/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit had an electrical test failure #120.There was no patient involvement.
|
|
Event Description
|
It was reported that when being powered on in clinical mode, the cs300 intra-aortic balloon pump (iabp) unit had an electrical test failure #120.There was no patient involvement.
|
|
Manufacturer Narrative
|
A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the power management board, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released for cleared for clinical service.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|
|
|