Testing of actual/suspected device (10/3243): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed physical damage to the cart and rescue unit.The damage would not allow the cart and rescue to connect properly causing the power issue.The fse replaced the rear-left cart panel, lower and upper display bezel, upper hinge cover display and related labels.Once the parts were replaced and some of the bent metal was straightened, the iabp unit began to work.Subsequently, the fse performed preventative maintenance (pm) and 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.Trend analysis: (4110/3243) the overall 24 month product complaint trend data for the period (sep 2019 through aug 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.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.
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