Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2018 – 29.12.2018

Опубліковано 08.01.2019 о 10:26

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

·         Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO – Risk of total loss of patient ventilation (MDA/2018/037)

Manufactured by Acutronic Medical Systems AG – Ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.

Medical device alert

Anaesthetics and 3 others

Issued:

21 December 2018

·         Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.

Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.

Medical device alert

Anaesthetics and 21 others

Issued:

29 November 2018

·         All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035)

Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump

Medical device alert

Care home staff and 3 others

Issued:

14 November 2018

·         Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging (MDA/2018/034)

Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections.

Medical device alert

Anaesthetics and 18 others

Issued:

14 November 2018

·         CoaguChek Test Strips for Point of Care and Home Use – risk of false high results (MDA/2018/033)

Manufactured by Roche Diagnostics GmbH: affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions

Medical device alert

Anaesthetics and 21 others

Issued:

8 October 2018

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