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
Component Incompatible (1108)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/15/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
During a preventative maintenance (pm) service, the getinge field service engineer (fse) observed a missing iv pole, to fix the issue the fse ordered and installed the new iv pole.The fse then performed a full pm with calibration, functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
|
|
Event Description
|
It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), observed a missing iv pole on the cardiosave intra-aortic balloon pump (iabp).There was no patient involvement, and no adverse event reported.
|
|
Search Alerts/Recalls
|
|
|