China NMPA Product Recall - Defibrillation/monitoring system

Physio-Control, Inc. initiated a voluntary Class III recall of its LIFEPAK 15 defibrillator/monitoring systems, as announced by the National Medical Products Administration (NMPA) on November 29, 2016. The recall was reported by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd. and addresses a specific technical issue with the device's EtCO2 display.

The core problem involves the EtCO2 (End-tidal Carbon Dioxide) value display. When the LIFEPAK 15 is configured to show EtCO2 in kPa or percentage (%) settings, and the reading surpasses 9.9, the display may partially obscure the actual value. This display anomaly could potentially lead to incorrect interpretation of vital patient information, which is critical for clinical decision-making in emergency and monitoring situations.

The regulatory framework for this action falls under the NMPA, overseeing medical devices in China, including imported products like this one (Registration No.: CFDA (Imported) 2012 No. 3212890 (Revised)). While specific inspection dates are not detailed, the recall itself is a direct response to this identified product defect.

As a Class III recall, it signifies that the use of or exposure to the affected product is unlikely to cause serious adverse health consequences. Physio-Control, Inc. is taking the required action of a voluntary recall to rectify this display issue, aiming to maintain patient safety and ensure the reliability of its devices. Comprehensive details regarding the specific models impacted are provided in the "Medical Device Recall Event Report Form" attachment.