The report of the autopulse platform ((b)(4)) displaying a ua 45 (driveshaft not at "home" position after power-on/restart) error message was reproduced during functional testing and confirmed during archive data review.The autopulse platform is a reusable device and was manufactured on 13-mar-2008.It has exceeded its expected service life of 5 years, the device is over 10 years old.Evaluation of the platform during initial power up, revealed a ua 45 error message on the user control panel.The root cause is due to a defective driveshaft.The archive data was reviewed and confirmed the occurrence of the ua 45 error message on the reported event date of (b)(6) 2018.As part of routine service during testing, the device was examined and found physical damage.A load characterization check was performed and indicated a defective load cell.The defective driveshaft, observed physical damage, and defective load cell are all attributed to the wear and tear due to the age of the device.After replacement of the driveshaft, damaged parts and load cell, the platform was further tested and passed all final specification.Historical complaints were reviewed for service information related to the reported complaint and ccr (b)(4) was reported on (b)(6) 2014 for a ua 45 due to a driveshaft not being in home position.
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During routine inspection, the autopulse platform ((b)(4)) displayed an ua 45 (driveshaft not at "home" position after power-on/restart) error message.The user was unable to resolve the issue.Additionally, physical damage was also observed on the area near the driveshaft.No patient involvement.
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