# China NMPA Product Recall - Semi-automatic external defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/4e951430-90ce-426b-9464-adb05149c6a6/
Source feed: China

> China NMPA product recall for Semi-automatic external defibrillator by Physio-Control, Inc. published October 11, 2017. Recall level: Level 1. Physio-Control, Inc. initiated a voluntary global recall of its LIFEPAK 1000 semi-automatic external

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Physio-Control, Inc. Active recall of semi-automated external defibrillators
- Company Name: Physio-Control, Inc.
- Publication Date: 2017-10-11
- Product Name: Semi-automatic external defibrillator
- Recall Level: Level 1
- Recall Reason: The device may unexpectedly shut down during patient treatment. In this case, the defibrillator may fail to function during resuscitation, putting the patient at risk of serious harm or death. Such unexpected shutdowns are caused by intermittent poor contact between the battery and the device. Investigation revealed that this intermittent poor contact is due to wear and subsequent oxidation between the battery and the device's electrical contacts. This has been observed to occur if the device is used under vibration conditions and the battery is installed for an extended period without the LIFEPAK 1000 battery being removed, inspected, and reinstalled.
- Discovering Company: Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd.
- Manufacturing Company: Physio-Control, Inc.
- Summary: Physio-Control, Inc. initiated a voluntary global recall of its LIFEPAK 1000 semi-automatic external defibrillators, as announced by the National Medical Products Administration (NMPA) on October 11, 2017. The recall, categorized as Level 1 due to potential for serious harm or death, addresses a critical issue where devices may unexpectedly shut down during patient treatment. This malfunction stems from intermittent poor contact between the battery and the device's electrical contacts, caused by wear and subsequent oxidation, particularly when devices are used under vibration and batteries are left installed for extended periods without inspection. Physio-Control, Inc., through its distributor Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., instructed customers to immediately remove and reinstall the LIFEPAK 1000 battery. Users are required to regularly perform this battery reinstallation weekly to clean contacts and reduce oxidation, keep a fully charged spare battery, and arrange for repair service if the issue persists. In China, 602 affected units were imported, with 361 units sold.

Company: https://www.globalkeysolutions.net/companies/physio-control-inc/c025f05e-3b2b-4081-a12e-0e310448bbe6/