# China NMPA Product Recall - Efficia DFM100 External Defibrillator Monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-kincoway-shenzhen-industrial-co-ltd/73a3b901-2736-4772-ab0e-e61e962ba3bf/
Source feed: China

> China NMPA product recall for Efficia DFM100 External Defibrillator Monitor by Philips Kincoway (Shenzhen) Industrial Co., Ltd. published September 15, 2020. Recall level: Level 2. On September 15, 2020, the National Medical Products Administration (NMPA) announced a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Kinco (Shenzhen) Industrial Co., Ltd. voluntarily recalls external defibrillator monitors.
- Company Name: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Publication Date: 2020-09-15
- Product Name: Efficia DFM100 External Defibrillator Monitor
- Recall Level: Level 2
- Recall Reason: The Efficia DFM100 external defibrillator monitor lacks a treatment cable loop, which may cause intermittent issues at the treatment cable interface, leading to treatment delays or inability to provide treatment.
- Discovering Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Manufacturing Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Summary: On September 15, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Philips Kinco (Shenzhen) Industrial Co., Ltd. for its Efficia DFM100 external defibrillator monitors. The recall was prompted by critical customer feedback revealing that newly supplied devices were missing essential treatment cable loops. This significant defect poses a serious risk, as the absence of these components can lead to intermittent malfunctions at the treatment cable interface, potentially causing delays in critical medical treatment or even rendering the defibrillator inoperable during emergencies. Given the vital function of defibrillators in life-saving situations, such a malfunction represents a substantial safety concern for patients. Philips Kinco proactively undertook this recall action to mitigate potential harm, demonstrating adherence to regulatory expectations. The Class II classification indicates that the product defect could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Comprehensive details regarding the specific affected product models, specifications, and batch numbers are documented within the "Medical Device Recall Table" and the accompanying Philips Recall Incident Report Form.

Company: https://www.globalkeysolutions.net/companies/philips-kincoway-shenzhen-industrial-co-ltd/fe26b37f-e114-43d2-b1a3-85beed6a47a7/