WhaleTeq Test Solutionsfor
Medical Device Manufacturers

The Automated External Defibrillator (AED) is known for its user-friendly and life-saving characteristics, but its electronic nature can easily be overlooked. Without timely inspection and maintenance, abnormalities and misjudgments may occur. 

According to FDA, there have been numerous cases of AED failure resulting in the death of the patient, with at least 750 deaths linked to AED malfunction among 72,000 reported incidents from 2005 to 2014. In response, the FDA imposed stricter premarket approval rules (PMA) for AED manufacturers in 2015. Several AED manufacturers have also recalled their products, with 12 recalls recorded from 2008 to 2020 on the FDA's website.

Although the use of AEDs can significantly reduce the risk of death from abnormal heart rhythms, there are still many challenges to be faced, such as the need for regular maintenance test to be compliant and keep proper use.

To address these issues, WhaleTeq has developed AED CMMS that improves the compliance and efficiency of managing AEDs through regular testing, AED managing platform, and the application of IoT technology. Both AED maintenance providers and owners can easily manage their AEDs, monitor its status in real-time, ensure performance, reduce risk, and fulfill their responsibilities with peace of mind.