The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.
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The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.Because the problematic blades were not returned, we were unable to confirm the complaint.However, by collecting available samples of the same p/n, we were able to replicate the intubrite handle and sunmed blade combination.When testing, the sunmed blade light up just as easily as the intubrite blade.When light output was measured, the sunmed blade was even higher than the intubrite.The issue the customer had with their sunmed blade could have been because of user preference and experience with only the intubrite blades.The risk analysis (rma-20002b) presented r20 as a comparable risk id.This risk item has a severity of 7 = extreme, but is below an 8 and is not required for review at carb.Reportable because of delayed intubation attempts and placement of the laryngoscope.No patient harm was reported.
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