|
Catalog Number CON-HL-390 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
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.Received device in good condition.Found liquid crystal leakage on the liquid-crystal display (lcd).The root cause of the reported issue was found to be a bad lcd on control board; liquid crystal leakage.Actions were taken to mitigate the reported issue: replaced the power control board.
|
|
Event Description
|
It was reported that the warmer had a damaged liquid-crystal display (lcd).No patient injury was reported.
|
|
Search Alerts/Recalls
|
|
|