The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom posted a medical device safety alert concerning Defibrillation Electrode SKINTACT DF29N manufactured by Leonhard Lang. The affected article number is 50028.
During an investigation triggered by customer feedback, the manufacturer discovered that it can be aggravated to connect these defibrillation electrodes with the defibrillator Welch Allyn AED 10. As a consequence, it may happen that the user does not connect the electrodes with the defibrillator in an emergency situation.
According to the manufacturer, there is a risk that the affected electrodes will be connected with the defibrillator only with delay or not at all. This may cause a situation in which a patient, who is in a life-threatening condition and requires a defibrillation shock, cannot be treated in good time.
The manufacturer advises users to quarantine and destroy all unused affected products.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-12-16-september-2016
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 September 2016