Medical Device Alerts issued in September 2017

Alerts were recently issued about Accu-Chek insulin pumps, Astral lung ventilators, and IntelliVue patient monitors used with 12-lead ECG.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 26 October 2017

• Therapeutic area: Anaesthesia and intensive care, Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism, Respiratory disease and allergy

In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

Alerts were recently issued by MHRA about:

• All Accu-Chek® Insight insulin pumps – risk of alarm failure
• Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery
• IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion; specific models and software versions affected

Article citation: Drug Safety Update volume 11, issue 3; October 2017: 6.

Published 26 October 2017