This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed poor, old style power switch was broken loose off the printed circuit board.Customer?s reported issue was duplicated.Power switch was broken off the printed circuit board causing the device to have no power.The root cause of the reported issue was determined to have been caused by normal wear and tear.This device uses an old-style printed circuit board where the power switch is soldered onto the board.The power switch was broken off.Actions taken to mitigate the reported issue: no action taken due to the age and condition.Device is deemed beyond economical repair and will be scrapped.Udi information is unknown.Initial reporter also sent report to fda is unknown.No information has been provided to date.Report source is unknown.
|