# China NMPA Product Recall - Semi-automatic external defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/96805fa5-6515-4d6f-827e-225c74a60962/
Source feed: China

> China NMPA product recall for Semi-automatic external defibrillator by Physio-Control, Inc. published October 11, 2017. Recall level: Level 1. On October 11, 2017, the National Medical Products Administration (NMPA) announced a Level 1 global 

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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: On October 11, 2017, the National Medical Products Administration (NMPA) announced a Level 1 global recall initiated by Physio-Control, Inc., for its LIFEPAK 1000 semi-automatic external defibrillators. Distributed in China by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., these devices presented a critical safety issue: the potential for unexpected shutdown during patient treatment. This malfunction posed a serious risk, potentially leading to severe harm or death if the defibrillator failed during resuscitation efforts. The core problem was identified as intermittent poor contact between the battery and device electrical contacts, resulting from wear and oxidation, especially when devices were used under vibration or batteries were installed for extended periods without re-installation. As a required action under this regulatory framework, Physio-Control, Inc. instructed customers to immediately remove and reinstall the defibrillator battery to clean contacts and mitigate oxidation. Furthermore, users were advised to regularly (weekly) remove and reinstall batteries in all LIFEPAK 1000 devices, maintain a fully charged spare battery, and contact for repair service if the problem persisted.

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