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
Connection Problem (2900)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/29/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that during a daily check, the blood pressure (bp) cable for the cardiosave intra-aortic balloon pump (iabp) was unable to connect into the console.There was no patient involvement, and no adverse event was reported.
|
|
Manufacturer Narrative
|
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replicated the reported issue and was unable to connect the bp adapter cable to the console.The bp connector had a tab blocking the cable from fully seating into the console.The fse noted that despite the issue, the iabp unit was still functional.Additionally, the fse observed external damage.The fse replaced the front end module and updated the software.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.
|
|
Search Alerts/Recalls
|
|
|