Corrected data: d9 - date device returned to manufacturer.Vyaire medical file identification: (b)(4).Device evaluation: d9, g3, g6, h2, h10.The component was visually inspected.It was recognized that the white tube had fallen out and was not attached.Inspection showed that the white tube was not glued correctly.Patient risk to swallow the plastic part is very limited because the dvt is inserted in a face mask.The risk for a patient to swallow the part is very low as it would drop and rest in the mask.Additionally, in the case of a spirometry without a mask, a microgard ii filter must be used which is directly connected between the patient and the dvt.It was determined that the root cause for the reported issue was the white tube was not glued correctly.The manufacturer was unable to determine a reason as to why the white tube was not glued correctly.
|