The autopulse platform ((b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and no damages were observed to the platform.Functional testing was completed, including performing compressions, and no issues were noted.Load cell characterization was also performed and the load cells were found to be performing per specification.A review of the archive was performed and the reported complaint was confirmed.User advisories 2 (compression tracking error), 17 (max motor on-time exceeded during active operation) and 7 (discrepancy between load 1 and load 2 too large) were all found to have occurred on the reported event date of (b)(6) 2014.Further inspection did not identify any mechanical issues with the platform that may have caused or contributed to the observed user advisories.A possible cause for ua 2 and ua 7 could be due to the load cells not functioning properly, however as noted in earlier functional testing, the load cells for the returned platform were performing as intended.A possible cause for ua 17 could be due to the platform's brake gap being out of specification, however inspection of the device did not confirm this to be an issue.Based on all evaluation results, the cause of the reported ua faults could not be definitively determined.Based on the investigation, no parts were identified as needing replacement.In summary, the reported complaint was confirmed during archive review, however a definitive cause for the reported faults could not be identified during internal visual inspection or functional testing.There were no mechanical issues identified with the platform that could have potentially led to the reported faults.Following service, the device passed all testing criteria.
|