Updated fields: b4, e2, e3, g3, g4, g7, h2, h3, h6, h10, h11.Corrected fields: h6 (medical device - problem code, investigation findings, component codes, investigation conclusions).A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed a broken fiber optic balloon connector and the connector for the balloon would not latch.The fse replaced the fiber optic assembly then verified proper fiber optic function and output.Subsequently, 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.Historical data analysis: (4109/3243) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110/3243) the overall 24 month product complaint trend data for the period (jul 2019 through jun 2021) was reviewed.There were no triggers identified for the review period.Analysis of production: (3331/3243) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported 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.
|