DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-0800-53 |
Device Problem
Failure to Zero (1683)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/27/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) a line was unable to zero.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.
|
|
Manufacturer Narrative
|
The full name of the initial reporter is (b)(6).Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The fse tried to duplicate the symptoms for about two hours and used the customer's trainer thinking that was the problem.All functional and safety checks were performed to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
|
|
Search Alerts/Recalls
|
|
|