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
Communication or Transmission Problem (2896)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/18/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.Fse confirmed that touchscreen would not work intermittently.To fix the issue, the fse recalibrated the touchscreen 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 to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) touchscreen panel was not working.There was no patient involvement, and no adverse event reported.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Updated fields: b4, g4, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10.
|
|
Search Alerts/Recalls
|
|
|