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
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/18/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that before use discovered by hospital personnel, the cardiosave intra-aortic balloon pump (iabp) unit failed leak test five times.There was no patient involvement.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Manufacturer Narrative
|
A getinge field service engineer (fse) evaluated the unit, but was unable to reproduce the reported malfunction.The fse performed a full preventive maintenance (pm) per manufacturer specifications.The unit passed all tests and calibrations.The iabp was ready for clinical use.
|
|
Search Alerts/Recalls
|
|
|