Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.09.2016 – 30.09.2016

Опубліковано 30.09.2016 о 00:00



·         AIRVO™2 and myAIRVO™2 humidifier – risk of undetected auditory alarm

Manufactured by Fisher & Paykel Healthcare Ltd – updated instructions for use to check the speaker before each use as undetected auditory alarms could result in the patient becoming hypoxic.

Alert type: Medical device alert Issued: 2 September 2016

·         Accu-Chek® Insight Insulin pump system: risk of over- or under-infusion of insulin

Manufactured by Roche Diabetes Care – inadequately detailed handling instructions of the ‘Key Lock’ function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis.

Alert type: Medical device alert Issued: 1 September 2016


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