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Contributor: PR Newswire Asia (Hong Kong)
Friday, June 24 2022 - 14:00
AsiaNet
WhaleTeq: Widespread as AEDs Are, Have These Life-Saving Machines Really Come in Handy?
TAIPEI, June 24, 2022 /PRNewswire-AsiaNet/ --

Unlike most products, AEDs sit idle most of the time. However, a life-or-death 
situation follows when it's being used. The consequences can be tragic if an 
AED isn't properly maintained. WhaleTeq, a professional medical device test 
solution provider proposed a simple but accurate way to conduct AED maintenance 
check - DFS200, an AED Field Tester.

Every year, sudden cardiac death takes the lives of 7 million people around the 
world, accounting for about 40% of the total death toll, seriously threatening 
people's lives and health.

AED, an automated external defibrillator, regarded as a "life-saving machine", 
is undoubtedly the savior of cardiac arrest patients. It can automatically 
determine whether the patient needs electric shock and help the patient to 
restore the normal rhythm and contraction of the heart. Besides, AEDs are 
designed for use by laypersons with very little training because of its easy 
operation.

AED Failures Heard from Time to Time, A Life-Or-Death Situation No One Can 
Afford to Ignore

AED has the characteristics of simple operation and can be used by anyone, but 
people ignore that AED is not a panacea. Malfunction may occur, and making 
mistakes in judgment is not out of expectation. There have been many cases of 
patients dying due to AED failures in the user anomalies reported by the US FDA 
and IEEE.

According to FDA data in 2015 
(https://www.raps.org/regulatory-focus%e2%84%a2/news-articles/2015/2/high-failur
e-rate-for-aeds-prompts-fda-change-in-regulatory-policy), between 2005 and 
September 2014, a total of 72,000 users reported abnormality, and at least 750 
deaths may have been caused by AED failures. FDA has thus announced that AED 
manufacturers should comply with stricter going-to-market rules 
(https://www.federalregister.gov/d/2015-01619) since that year. (PMA, Premarket 
Approval).

IEEE's previous data further pointed out that from 2005 to 2009, there were 
28,000 abnormal reports, equivalent to 1 failure out of every 50 reports. Among 
them, 17 of the most serious conditions included diagnostic errors, incorrect 
instructions, and unnecessary shocks, but the deadliest problem was no power 
supply after pressing the shock. 

In Japan, 2014 is the tenth anniversary of the Japanese government's opening to 
the public for free use of AEDs. NHK TV produced a special report program 
(https://www.nhk.or.jp/seikatsu-blog/400/193639.html#more), pointing out that 
there were 103 serious problems of AED failures in the past 9 years, of which 
42 cases were incapable of saving their lives. Worse cases include inability to 
shock and dead batteries.

The Risk of AED Being out of Warranty- Losing the Chances to Save Lives

When a critical situation occurs, it is almost impossible to save lives because 
of AED failures, which is a situation that everyone is not happy with. Like 
other electrical appliances, AEDs may also have problems with failure and 
longevity. Although AED brands vary, the warranty period is usually five to 
eight years. With the premise that most AEDs have been set up without regular 
maintenance, its availability is indeed a concern.

In general, after AED has passed the warranty date, the manufacturers are no 
longer responsible for providing aftercare and maintenance, and the law doesn't 
punish those who fail to fulfill their management responsibilities. Outdated 
AEDs are either discarded or left idle in the corner, becoming "AED orphans".

If people can conduct AED maintenance check regularly, replacing its disposable 
parts in a timely manner, the efficiency and effectiveness of AED can be 
ensured, which also improves life-saving success rate.

Maintenance Check on a Regular Basis Increases Life-Saving Possibilities

However, what many people don't know is that the AED self-test cannot detect 
all possible failures. Even AEDs do have automated self-tests, but if no one is 
actively maintaining the device and able to respond to a failed self-test, this 
feature is obsolete. 

Specifically, an AED self-test can only confirm its MCU and firmware status but 
numbers like defibrillation energy, waveform and remaining power of battery are 
excluded. In addition, abnormal problems such as inability to shock, 
insufficient energy, charging for too long, and power overconsumption derived 
from aging parts are not able to be known through self-test.

For AED managers, self-test does provide a simple way to confirm AEDs' 
availability, but people also need a way that can provide more detailed and 
complete information. For example, people need the engineer to test on-site, 
including defibrillation energy and waveform, battery voltage and upload data 
of each AED device to the cloud database, completely recording its maintenance 
check history.

DFS200, an AED Field Tester launched at the Right Time

In the light of this, WhaleTeq launched DFS200. Engineers can easily test every 
function mentioned in the previous paragraph through AED field tester DFS200, 
including AED defibrillation energy and waveform, lithium battery voltage, and 
generate a variety of ECG waveforms for AED to determine whether defibrillation 
is required.

At the same time, this AED field tester DFS200 can be used in pairs with 
management platform, pointing out parts that might not be functional according 
to the big data. It helps users not only to save time, but also to improve the 
quality of it. The management platform can also set a maintenance check 
notification, disposable parts changing reminder, and automatically assign them 
to the engineers, thereby saving more manpower and time for AED managers.

More info: https://reurl.cc/Xjy8e7

About WhaleTeq Co. Ltd

Founded in September 2013, WhaleTeq provides first-class test solutions, 
including test equipment and associated services for medical devices. We strive 
to assist our clients in launching their top-quality medical devices to the 
market in the most efficient way. Our specialty lies in physiologic monitoring 
systems testing, such as ECG, EEG, PPG, SpO2, respiration monitor testing. We 
are honored to work with renowned medical device providers such as GE, Philips, 
Siemens, Medtronic, as well as international laboratories such as UL, SGS, TUV 
and CSA.

SOURCE: WhaleTeq

Image Attachments Links:

   Link: http://asianetnews.net/view-attachment?attach-id=423969

   Caption: DFS200 is an AED field tester, controlled and communicated via APP 
through smartphone Bluetooth connection. Apart from self-test, DFS200 is able 
to test defibrillation energy and waveform, lithium battery voltage, and 
generate a variety of ECG waveforms for AED to determine whether defibrillation 
is required.

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