The customer reported complaint for the platform displayed an error message user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during archive data review and functional testing.Load cell was found defective and a replacement was required.Visual inspection was performed and found cracked front enclosure and a missing grip strip.Front enclosure and a missing grip strip were replaced to address the issue.The autopulse platform is a reusable device as well as a serviceable device and was manufactured in 2010.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.The platform has also exceeded its expected service life of 5 years.Following the repair, the platform was further tested for 15 minutes with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and passed all functional testing criteria and met all required specifications.During functional testing, (ua) 07 error message displayed upon powered on the device, thus confirming the reported complaint.Review of the archive data indicated error messages (ua) 07 on the customer reported event date.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).
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