The sensor involved in this event was not returned, however retained samples were available for evaluation.The sensor was evaluated and passed all testing including a visual evaluation, continuity testing and skin temperature verification.The sensor tested was confirmed to function as designed.A product labeling review was conducted which included reviewing the directions for use (dfu).The user facility was contacted and appropriate instruction and clarification was provided to augment training they have already received.Info masimo receive indicated that the pt is doing fine outside of their underlying condition.The pt has been discharged from the picu.
|