The reported complaint was confirmed during the device initial functional testing.The autopulse platform stopped compression due to multiple error messages ua 7 (discrepancy between load 1 and load 2 too large) verified in the archive data.The load sensing system has detected a weight/load imbalance between the two load cells.It was determined that the probable cause of the reported issue was due to over-reported (defective) on both load cell modules.Review of the archive data verified the reported (ua) 7 (discrepancy between load 1 and load 2 too large) error message, and initial functional testing of the autopulse platform could not be performed due to error message prompted on the screen.Unrelated to the reported complaint, during visual inspection, cracked front and bottom covers were observed, this types of physical damages on the device can occur due to normal wear and tear.The autopulse platform is a reusable device and was first manufactured on 01 oct 2010.The device has been operating for nearly 8 years and has exceeded its expected serviceable life of 5 years.After the removal of both front and bottom covers, wide corrosion and fluid damaged to the metalized inner surface of the autopulse blue (top) cover were observed.The blue top and bottom covers were replaced and as required, the unit was also bio-cleaned.Historical complaints were reviewed for service information relating to the reported complaint.As a result, there was no previous history of complaints reported for autopulse platform serial number (b)(4).
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As reported, during patient use, the autopulse platform (b)(4) stopped compressing and then prompted a user advisory error message ua 7 (discrepancy between load 1 and load 2 too large).The users tried adjusting the imbalance patient on the device but were unsuccessful clearing the ua 7 error message.Patient care was not compromised from the device's issue.Hence, no known impact or consequence to patient.
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