PR96663

TAIPEI, June 24, 2022 /PRNewswire=KYODO JBN/ --

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.