# China NMPA Product Recall - Semi-automatic external defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/1d4f6005-3067-403b-805a-a67f11fa7a05/
Source feed: China

> China NMPA product recall for Semi-automatic external defibrillator by Physio-Control, Inc. published October 10, 2017. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced a Level I global voluntary recall on O

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Physio-Control, Inc. Active Recall of Semi-Automatic External Defibrillators
- Company Name: Physio-Control, Inc.
- Publication Date: 2017-10-10
- Product Name: Semi-automatic external defibrillator
- Recall Level: Level 1 Recall
- Recall Reason: The device may unexpectedly shut down during patient treatment. In such cases, the defibrillator may fail to function during resuscitation, potentially exposing the patient to serious harm or death. This unexpected shutdown is 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 device 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: The National Medical Products Administration (NMPA) announced a Level I global voluntary recall on October 10, 2017, initiated by Physio-Control, Inc., for its LIFEPAK 1000 semi-automatic external defibrillator (NMPA registration 20163212101). The recall, managed by agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., addresses a critical safety concern: the device may unexpectedly shut down during patient treatment, potentially failing to function during resuscitation and posing a risk of serious harm or death. The issue stems from intermittent poor contact between the battery and the device's electrical contacts, caused by wear and subsequent oxidation. This problem is observed to be aggravated under conditions of vibration and prolonged battery installation without routine removal, inspection, and reinstallation. To rectify this, Physio-Control requires customers to immediately remove and reinstall the battery in all affected LIFEPAK 1000 units to clean oxidized contacts. Users must also regularly remove and reinstall all spare LIFEPAK 1000 batteries weekly and ensure a fully charged spare battery is readily available. For persistent problems, repair services will be arranged.

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