# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/854b7839-f27c-4088-a607-8d4e7a772b3c
Source feed: China

> China NMPA product recall for Monitor defibrillator by Philips Medical Systems published January 27, 2015. Recall level: . Philips (China) Investment Co., Ltd., in collaboration with its manufacturer Philips Medical Systems

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. expands recall of patient defibrillators
- Company Name: Philips Medical Systems
- Publication Date: 2015-01-27
- Product Name: Monitor defibrillator
- Recall Reason: Issue 1: When connected to AC or DC power, operated with a LAN cable, or near a power source prone to EFT interference, the MRx may be susceptible to interference from Electrical Fast Transient Bursts (FETs), potentially leading to delayed treatment or unexpected delivery. Issue 2: The MRx may exhibit unintended performance if the user follows either of the following two non-standard clinical workflows. These workflows do not conform to the MRx Instruction of Use (IFU) and are not intended for use by trained clinicians. Furthermore, this situation has only occurred during internal testing and has never occurred in clinical use. The workflow and related equipment are as follows: Workflow A: When defibrillating using an external defibrillator pad, the MRx may deliver a shock if the user presses only one of the two shock buttons in the following sequence. 1. When the MRx is in manual defibrillation mode and an external defibrillator handpiece is used; 2. The user presses and holds the single button “Apex” on the external defibrillator handpiece and rotates the “Treatment” knob to any other clinical mode (monitor, pacemaker, AED); 3. The user releases the button held on the external defibrillator handpiece; 4. The user rotates the MRx to any manual defibrillation energy and presses Charge; 5. The user accidentally presses the button “Sternum” on another external defibrillator handpiece. When this single button is pressed, the MRx will deliver a shock. Pressing the single button will continue delivering a shock until the device is turned off. Note: The Apex and Sternum buttons on the defibrillator handpieces can be interchanged to reproduce the problem. Workflow B: When using the MRx with the Periodic Clinical Data Transmission (PCDT) option, the MRx may restart if the following sequence is followed: 1. In monitor mode, PCDT is turned on and transmitted, and the user switches from monitor mode to manual defibrillation mode. 2. When the display switches from monitor mode to manual defibrillation mode, the user presses the “Sync” button. 3. The MRx restarts, reactivating within 6-8 seconds. Issue 3: Because the ECG lead may detach when the ECG electrode pads measure skin resistance outside the design range, the MRx may stop on-demand pacing. Note: Philips had previously improved the performance of this MRx to maintain ECG monitoring in cases of high skin contact resistance. However, these improvements are not used on devices with software version B.06.XX (revision). (Recall document internal number FCO 86100160)
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., in collaboration with its manufacturer Philips Medical Systems, announced an expanded recall of its Monitored Defibrillator models M3535A and M3536A on January 27, 2015. This action, overseen by the National Medical Products Administration (NMPA), added 31 devices to the existing recall scope in China, bringing the total affected units to 3751 globally.The recall addresses critical performance issues. Firstly, the MRx defibrillator is susceptible to electrical interference (Electrical Fast Transient Bursts) when connected to power or LAN, potentially leading to treatment delays or unintended shock delivery. Secondly, the device exhibited unintended behavior under specific non-standard clinical procedures not outlined in its Instructions for Use. This included accidental shock delivery if only one external defibrillator handpiece button was pressed under certain conditions, and device restart when transitioning modes with active data transfer and the 'Synchronize' button pressed. Lastly, the MRx might fail to perform on-demand pacing due to ECG lead dislodgement when skin resistance falls outside the design range, particularly on devices with specific software versions.To resolve these issues, Philips is providing a free software upgrade for all affected devices. Company representatives will directly contact users to facilitate the installation of this essential corrective measure, ensuring device safety and reliability.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47