DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-3023-55 |
Device Problems
Component Incompatible (1108); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/17/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A getinge field service engineer (fse), replaced ((b)(4)) drive manifold to solved the reported issue.After replacement, the system failure code disappeared.The fse then performed all functional and safety checks to meet factory specifications.The iabp was returned to the customer and cleared for clinical use.
|
|
Event Description
|
It was reported that during turn on, before use, the cs300 intra-aortic balloon pump (iabp) has a system failure.There was no patient involvement, and no adverse event report ed.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Additional customer contact information was provided and is as follows: (b)(6).Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period mar-2019 through feb-2021was reviewed.There were no triggers identified for the review period.
|
|
Search Alerts/Recalls
|
|
|