# China NMPA Product Recall - Patient monitor; patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/6291381b-3df8-4a90-8c1e-f76d6aa6b6e1/
Source feed: China

> China NMPA product recall for Patient monitor; patient monitor by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published June 08, 2020. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling patient monitors.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2020-06-08
- Product Name: Patient monitor; patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: When the Patient Data Module (PDM) is used with B450/B650/B850 patient monitors or Solar 8000M/8000i patient monitors, if Pace detection is enabled on the monitor and an automated external defibrillator (AED) is used for defibrillation, the low-frequency signal from the AED will cause the PDM to issue incorrect ECG information, displaying cardiac arrest on the monitor and triggering an alarm. This issue may delay clinical evaluation for ECG arrhythmias.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for several models of its patient monitors. This action, reported on June 8, 2020, by the Shanghai Municipal Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses a significant safety concern.The core issue occurs when the Patient Data Module (PDM) is utilized with specific GE patient monitors (B450, B650, B850, Solar 8000M, Solar 8000i). If pacing detection is enabled on the monitor and an automated external defibrillator (AED) is subsequently used, the AED's low-frequency signal can cause the PDM to generate incorrect ECG information. This leads to the monitor displaying a false cardiac arrest and activating an alarm.This malfunction is critical as it could delay essential clinical evaluation and intervention for actual cardiac arrhythmias. The recall encompasses patient monitors identified by various CFDA Import Registration Numbers, including 20073211603, 20143212974, 20143212922, 20143212977, 20193072135, 20183072623, and 20183072625. Comprehensive details regarding the affected product models, specifications, and batches are provided in the associated "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/