China NMPA Product Recall - Automated External Defibrillator

On August 18, 2020, the National Medical Products Administration (NMPA) published notice JGXX-2020-10393 concerning a Class III voluntary recall initiated by Physio-Control, Inc. for their Automated External Defibrillator (Registration Certificate No.: 20163212102). The issue was reported by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd.

The core problem identified is improperly sealed packaging for the electrode pads. This defect causes the pads to dry out prematurely, which can severely compromise the defibrillator's functionality. Specifically, affected devices may fail to detect patient connection, report critical information to the user, or experience a complete loss of power. These malfunctions present significant safety risks, as they could prevent the effective use of the device during a medical emergency, potentially jeopardizing patient outcomes.

Physio-Control, Inc. is conducting this recall voluntarily to address these deficiencies under the NMPA's regulatory oversight. While detailed information regarding specific models, specifications, and batch numbers is provided in the "Medical Device Recall Event Report Form," the required action involves the removal of these potentially defective Automated External Defibrillator units from further distribution and use. This action underscores the importance of maintaining medical device quality and ensuring patient safety within the Chinese market.