DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-3023-58 |
Device Problems
Erratic or Intermittent Display (1182); Appropriate Term/Code Not Available (3191)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 12/20/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that, the cs300 intra-aortic balloon pump (iabp) unit screen looks bad.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported that, during start-up, the cs300 intra-aortic balloon pump (iabp) unit screen looks bad.
|
|
Manufacturer Narrative
|
Updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10, h11.Corrected fields: b5.A getinge field service engineer (fse) evaluated the unit for the reported malfunction.Fse was able to reproduce the reported issue.In order to resolve the issue, the lcd was replaced.All functional and safety checks were performed and the unit passed all tests performed.The unit was returned to the customer in good working conditions.
|
|
Manufacturer Narrative
|
Updated data: b4, e1 (initial reporter and email), e2, e3, g2, g3, g6, h2, h10.
|
|
Event Description
|
N/a.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Udi related data quality updates only. providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
|
|
Search Alerts/Recalls
|
|
|