Medical device manufacturer, Leonhard Lang, has issued a medical device safety alert concerning its defibrillation electrodes. The affected models are: 50017 – SKINTACT (DF30L), 50018 – SKINTACT (DF32L), Mindray MR-61 (DF39G), 50611 – Mindray MR-61 (DF74GC), 50617 – CariAid (DF73GC), 50626 – Weinmann Pediatric (DF71G), 50636 – Osatu Pediatric KSA 0501 B (DF75G), 50645 – SKINTACT (DF72G), 59945 – SKINTACT (DF31L) and 59966 – SKINTACT (DF35L).
In the course of in-house shelf-life tests, performed in addition to accelerated aging tests, the manufacturer has identified the potential risk of sparkover, which may result in a malfunction of these defibrillation electrodes.
The potential malfunction can occur with these electrodes after a duration of storage of about 28 months or more. All electrodes with a duration of storage of 28 months or less show a faultless performance and can be used as usual according to the instructions for use.
According to the manufacturer, there is a risk that the affected electrodes will exhibit this malfunction before reaching the indicated expiration date. 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 precise cause for this is still under investigation.
The manufacturer requests users to immediately stop using and destroy the affected products. Product recall is on-going.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 February 2016