The primary report of the autopulse platform ((b)(4)) displaying "replace battery" message was not reproduced during functional testing of platform, and could not be confirmed through review of the retrieved archive data.The archive data recorded no session around the reported event date of (b)(6) 2018.The report of the platform displaying "replace battery" was not reproduced during functional testing of platform.The secondary report of the platform's user control panel is pixilated was confirmed during functional testing.It is attributed to defective user control panel lcd.The autopulse platform is a reusable device and was manufactured on 31 jan 2013.It has exceeded its expected service life of 5 years.As part of the routine service during testing, the platform was examined and observed a defective belt clip retainer.This observation is not related to the reported complaint.It is attributed to wear and tear.After replacement of the defective user control panel lcd and belt clip retainer, the platform was functionally tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and no previous history of complaint was reported for the autopulse platform with serial number (b)(4).
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As reported, during patient use the autopulse platform ((b)(4)) displayed "replace battery" error message.User used multiple fully charged autopulse li-ion battery and error message still occurred.Additionally, the user control panel on the platform is pixilated.No known impact or patient consequence was reported.No other information was provided.
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