China NMPA Product Recall - Ventilator

Newport Medical Instruments, Inc. initiated a voluntary recall of its HT 70 ventilators, specifically impacting Power Pac batteries, as announced by the National Medical Products Administration (NMPA) on June 17, 2013, following an initial report on May 6, 2013. The recall was prompted by critical battery display and power management issues. The primary defect involves the ventilator's display showing a full battery level when the actual capacity is significantly lower, leading to the device issuing a premature warning and switching to its internal backup battery. A second issue involves the ventilator immediately alarming and switching to backup power upon disconnection from AC electricity. While the internal backup battery provides approximately 30 minutes of operation, these malfunctions necessitate users to have an alternative power source readily available. No adverse patient impacts were reported at the time of the recall. Under the regulatory oversight of the NMPA, Newport Medical Instruments, Inc., through its responsible unit in China, Shanghai Newport Trading Co., Ltd., confirmed on-site corrective actions. The company committed to providing free replacements for affected Power Pac batteries, identified by specific serial numbers and version ranges (C to F). This recall affects 100 units sold in China, with 31 units remaining in inventory, out of a total of 131 units produced or imported globally. Provincial regulatory bodies were advised to enhance supervision of these products.