# China NMPA Product Recall - Semi-automatic external defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/fe87092c-ac97-4353-b393-936026613ba6/
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. has initiated a global Level 1 voluntary recall of its LIFEPAK 1000 semi-automa

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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. has initiated a global Level 1 voluntary recall of its LIFEPAK 1000 semi-automatic external defibrillators. This action was reported by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd. to the National Medical Products Administration (NMPA) on September 28, 2017, and publicly announced on October 11, 2017. The recall addresses a critical safety concern where the defibrillators may unexpectedly shut down during patient treatment. This malfunction is caused by intermittent poor contact and subsequent oxidation between the battery and the device's electrical contacts, particularly when batteries remain installed for extended periods under vibration without routine removal and reinstallation.

This defect presents a significant risk, potentially leading to serious patient harm or death if the defibrillator fails during resuscitation. The recall impacts 602 units manufactured or imported into China, with 361 units already sold. Under the NMPA's regulatory oversight, Physio-Control, Inc. requires customers to take immediate and ongoing corrective actions. Users must promptly remove and reinstall the LIFEPAK 1000 defibrillator battery to clean oxidized contacts. Furthermore, weekly removal and reinstallation of batteries for all LIFEPAK 1000 devices are essential to ensure equipment readiness. A fully charged spare battery should also be kept on hand. If the issue persists, customers are advised to arrange for repair services.

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