Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Type
malfunction
Event Description
Information received a smiths medicsl patient monitoring|bci oximeter disposables reported sensors show defects after 1 to 2 days in use.Customer stated they do not dissipate, provide incorrect measure values and the cables of new sensors are already exposed as missing cable covers.
Manufacturer Narrative
Other text: device was supplied.Further investigation will be done by the supplier.No further information is available.
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The device sometimes had no readings, wire interruption, adhesive tape was thin and stretched the root cause of the reported issue was found to be a user interface problem.Device will be returned to the supplier.