Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.02.2017 – 28.02.2017

Опубліковано 13.03.2017 о 00:00



·         Alaris® syringe pumps (GH, CC, TIVA & PK models) – risk of uncontrolled bolus of medicine.

Manufactured by CareFusion – Updates and replaces MDA/2016/023 as the manufacturer has now identified the potential for unintended bolus of medication when any syringe type is used in a pump that contains a broken spring in the plunger assembly.

Alert type: Medical device alert Medical specialism: Paediatrics and 1 others Issued: 20 February 2017

·         Reflection® dead blow mallet (all batches) – risk of exposure to lead particles

Manufactured by Smith & Nephew – cracking of the welds on the head of the mallet can result in lead particles escaping and entering the surgical wound, potentially resulting in effects associated with lead exposure.

Alert type: Medical device alert Medical specialism: Orthopaedics Issued: 17 February 2017

·         Oxylog 3000 and Oxylog 3000 plus ventilator – risk of failure

Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).

Alert type: Medical device alert Medical specialism: Anaesthetics and 2 others Issued: 8 February 2017


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