DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-3023-53 |
Device Problems
Detachment of Device or Device Component (2907); Incomplete or Inadequate Connection (4037)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/14/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The getinge field service engineer (fse) resolved the issue by installing a helium knob.The fse 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.A supplemental report will be submitted upon completion of our investigation.(b)(6).
|
|
Event Description
|
It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) was found to have a missing helium knob.There was no patient involvement, and no adverse event reported.
|
|
Manufacturer Narrative
|
Updated fields:b4, g3, g7, h2, h4, h6, h10, h11 corrected fields: g1, g6, h6 (medical device ¿ problem code).
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|
|
|