Philips said it has found a reboot error in some Efficia DFM100 defibrillators used by physicians.
The company reported to the Ministry of Food and Drug Safety that Efficia DFM100 models with a particular serial number stopped operation in an automated defibrillation mode and the system would reboot.
As it takes about 23 seconds to reboot the system, defibrillators with the reboot error might delay a cardiopulmonary resuscitation in an urgent situation, the company said.
Philips has supplied 140 units of Efficia DFM100 in the local market.
Globally, there are no reports of patients or users injured due to the reboot error of the product.
According to the company’s report submitted to the ministry, there was almost no possibility that the product could generate harm.
However, the company said it would provide safety notice to clients and offer a new version of the software to prevent an automatic reboot.
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