Catalog Number 0998-00-0800-53 |
Device Problem
Electrical /Electronic Property Problem (1198)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/19/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the solenoid control and executive processor board which corrected the issue.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
|
|
Event Description
|
It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) had error code 118.There was no patient involvement, and no adverse event reported.
|
|
Manufacturer Narrative
|
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 2021) was reviewed.There were no triggers identified for the review period.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|