It was reported that a trail carried out the following reports of erratic reading, 3 main issues were: the size of the ear probe was too big and proved difficult to position properly.The readings were very erratic ear and finger reading at least 2% different, tried new pleth to no avail.Several devices in the community team same issue.The readings did not marry up with those taken using the ward high dependency monitor ear pleths, also blood gas monitor tested against.The second model we trialed had more stable readings.No patient injury was reported.
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Manufacturing device history record review was not performed because the defective ear probe is not evaluated or testing during the manufacturing process.Manufacture records are retained by the supplier at their manufacturing site.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found device is in good conditions.No damages or defects.Functional testing found both values are valid, no difference and stable readings as expected.The root cause of the issue could not be determined.A non-conforming event has been elevated on a non-conforming report (ncr).This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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