Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.05.2020 – 30.06.2020

Опубліковано 01.07.2020 о 14:47

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

  1. Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)

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.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 15 others
    • Issued: 30 June 2020
  1. Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)

Manufactured by Philips Respironics – sudden loss of power due to component failure, which may not always be accompanied by an alarm or visual warning.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 2 others
    • Issued: 29 June 2020
  1. 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)

The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 18 others
    • Issued: 17 June 2020
  1. Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)

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)

    • Alert type: Medical device alert
    • Medical specialism: Care home staff and 3 others
    • Issued: 8 June 2020

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