The customer's reported complaint of the autopulse platform displayed user advisory (ua) 41 (patient temperature sensor failure) error message was confirmed in the archive review but not during the initial functional testing.There were no device deficiencies found during the evaluation of the platform, which could have caused or contributed to the reported (ua) 41 error message.Visual inspection was performed and found damaged front enclosure, unrelated to the reported complaint.Following the replacement of front enclosure, the device was further tested and passed all testing criteria with no issues or faults observed.The autopulse platform is a reusable device and was manufactured in oct 2012.It has exceeded its expected service life of 5 years.Review of the archive data show (ua) 41 error messages occurred on the reported event date.Functional testing was performed and found no issue.Additionally, as a precautionary measure, the temperature sensor cabling, the pca power distribution board, and the fan/bracket assembly were replaced.The storage and shift check conditions are not known; however, factors such as ambient storage condition (e.G., a fire truck in sun) or soft surface that may block air vents are known to cause ua 41 error messages in rare cases.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with serial number (b)(4).Ccr (b)(4), reported on (b)(6) 2015.Issue was not confirmed.Ccr (b)(4), reported on (b)(6) 2016.Issue was not confirmed.Ccr (b)(4), reported on (b)(6) 2016.The temperature sensor cabling was replaced.
|