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Korea orders inspection of Philips defibrillators over potential defects
By Sohn Ji-youngPublished : March 18, 2018 - 17:55
South Korea’s Ministry of Food and Drug Safety has ordered a full inspection of two defibrillator models by Philips Medical Systems over concerns of potential defects.
According to the ministry, the inspection concerns two defibrillator models produced and sold by the US-based medical equipment company from 2002 and 2013 -- the 861304 HeartStart FRx Defibrillator and the HeartStart HS1. The ministry has also ordered that new product usage guidelines be issued to device users.
A defibrillator is a medical device which administers an electric shock to the heart to restore its normal rhythm during a cardiac emergency. They come in automated models installed in public facilities for public use and manual models used by professional medical staff at hospitals.
Philips Korea will take charge of carrying out the safety guideline training to device users by March 31 and carry out the device inspection by May 31, according to the ministry.
Though there were no reported cases of defects in the two defibrillator models in Korea, the ministry said it ordered the inspection in accordance with similar actions being taken by health regulators abroad including the US, Europe, Japan and Australia.
In February 2017, nearly 50,000 units of the HeartStart MRx Monitor/Defibrillator were recalled in the US due to electrical and battery connection issues that may prevent the device from powering up, charging and delivering electrical shock therapy.
By Sohn Ji-young (jys@heraldcorp.com)
According to the ministry, the inspection concerns two defibrillator models produced and sold by the US-based medical equipment company from 2002 and 2013 -- the 861304 HeartStart FRx Defibrillator and the HeartStart HS1. The ministry has also ordered that new product usage guidelines be issued to device users.
A defibrillator is a medical device which administers an electric shock to the heart to restore its normal rhythm during a cardiac emergency. They come in automated models installed in public facilities for public use and manual models used by professional medical staff at hospitals.
Philips Korea will take charge of carrying out the safety guideline training to device users by March 31 and carry out the device inspection by May 31, according to the ministry.
Though there were no reported cases of defects in the two defibrillator models in Korea, the ministry said it ordered the inspection in accordance with similar actions being taken by health regulators abroad including the US, Europe, Japan and Australia.
In February 2017, nearly 50,000 units of the HeartStart MRx Monitor/Defibrillator were recalled in the US due to electrical and battery connection issues that may prevent the device from powering up, charging and delivering electrical shock therapy.
By Sohn Ji-young (jys@heraldcorp.com)
