Medical Device Alerts issued in June 2020

A summary of Medical Device Alerts recently issued by the MHRA.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 July 2020
• Last updated: 31 July 2020 — See all updates

• Therapeutic area: Anaesthesia and intensive care, Cardiovascular disease and lipidology and Infectious disease

In this monthly update, we highlight selected Medical Device Alerts and notices 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.

• Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018). Issued 30 June 2020. Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.

• Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016). Issued 17 June 2020. Philips HeartStart MRx Monitor/Defibrillators may fail to deliver therapy without alerting the user to a fault in the event of internal damage suffered during a drop or due to severe mechanical shock.

• Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015). Issued 8 June 2020. This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)

Article citation: Drug Safety Update volume 13, issue 12: July 2020: 4.

Published 31 July 2020
Last updated 31 July 2020 + show all updates

1. 31 July 2020

   Republished in order to change the display order of articles; content unchanged

2. 31 July 2020

   First published.