[Direct answer]In the Beijing area, if a patient suffers harm due to defects in medical devices, the patient has the right to choose to claim compensation from the medical institution according to law, or from the manufacturer or marketing authorization holder of the medical devices. According to Article 1223 of the Civil Code of the People's Republic of China, if a patient suffers harm due to defects in drugs, disinfection products, or medical devices, or due to the input of unqualified blood, the patient may request compensation from the marketing authorization holder, manufacturer, or blood supply institution of the drugs, or from the medical institution; after the medical institution compensates, it has the right to recover compensation from the responsible producers and others. At the same time, the patient can claim compensation according to the product liability rules in Article 1203. The prerequisite for claiming compensation are to prove that the device has defects, that the patient has suffered personal harm, and the causal relationship between the two, and if necessary, to fix it through medical damage or product quality appraisal. It is recommended to seal the medical records and devices as soon as possible and refer to the relevant provisions for further guidance.Legal services for personal injury and medical disputes.

1. Problem background and typical scenarios

Medical device defect-induced harm is the most specialized type of medical product liability. Typical scenarios include: fracture of orthopaedic implant plates and loosening of screws; abnormalities in cardiac stents and pacemakers; wear or dislocation of artificial joints; infection or rupture of infusion devices and catheters; and infections caused by devices that have not undergone standard sterilization. Disputes often arise over whether the defect lies with the device itself, the doctor's improper surgical procedures, or the patient's own immune rejection. Patients often face double-talk from hospitals, which claim "the device has a registration certificate and there's no problem", and from manufacturers, which blame "improper use". Clarifying the defect and causality is the key to successful claims. For subsequent issues such as loss of income and nursing care, these can be addressed in conjunction with other claims.Labor arbitration and work-related injury compensation servicesEvaluate the damage.

II. Key points of contention

There are three key aspects to such cases. Firstly, the determination of defects: whether the device fails to meet national or industry standards, whether there are design or manufacturing flaws, and whether adequate warnings and instructions have been provided are prerequisites for establishing product liability. Secondly, the causality: whether the damage is directly caused by the defect, or by surgical procedures, the patient's condition, or rejection reactions, needs to be clarified through appraisal. Thirdly, the subject of liability and choice of legal remedies: patients can choose to sue either the medical institution, the manufacturer, or the marketing authorization holder, or sue all of them concurrently; the medical institution may recover compensation from the liable party after making compensation, which does not affect the patient's right to claim damages externally. For cases involving multi-institutional consultations or hospital transfers, reference can be made to relevant provisions.Special services and other case servicesTracing the chain of responsibility.

III. Professional analysis by Henglue Law Firm

Based on our practical observations in handling medical dispute cases, the most common pitfalls that patients face in claims for device defects are failing to seal the medical records and the devices involved in the case at the earliest possible time, and confusing "operational issues" with "product defects", which leads to misguided appraisal directions. Henglu Law Firm usually recommends the following: immediately copy and seal all medical records after detecting abnormalities postoperatively, and require the hospital to seal the suspected defective devices on site and not return or destroy them; as soon as possible, entrust professional institutions to determine whether the harm was caused by product quality or medical practices, as the evidence focus of the two paths is different. For cases involving disability, conduct a judicial appraisal to quantify the compensation after the treatment stabilizes. During the negotiation stage, do not easily sign a waiver of liability to settle the matter. First, have professionals calculate the project. For cases involving multiple entities seeking compensation, follow-up measures can be taken.Creditor-debtor relations and enforcement case services.

IV. Practical suggestions and legal basis

The legal basis is Article 1223 of the Civil Code (effective from January 1, 2021) (Liability for Medical Products and Claim Paths), Article 1203 of the Civil Code (Product Liability), and Article 1218 of the Civil Code (Liability for Medical Damage Due to Negligence); for administrative management, reference can be made to the Regulations on the Supervision and Management of Medical Devices (amended and implemented on June 1, 2021) regarding registration, production, and safety in use. Practical suggestions: immediately seal the medical records and the involved devices after the postoperative abnormalities, and do not let the hospital handle them unilaterally; apply for medical damage or product quality appraisals in a timely manner; sue or make parallel claims after identifying the responsible parties (hospital, manufacturer, or marketing authorization holder); and quantify the disability cases through appraisals. For cases involving insurance and multiple compensation, relevant provisions can be combined accordingly.Local personal injury appraisal resourcesAdvance.

5. Henglu Law Firm's Advice

The key to successfully claiming compensation for medical device defects lies in "sealing and appraisal": After the surgery, the medical records must be sealed immediately and the involved devices must be sealed on-site to avoid the loss of evidence; it is necessary to distinguish whether the harm is caused by product defects or medical actions, and to determine the direction of evidence collection and the responsible parties. It is strictly prohibited to sign a waiver of liability with the hospital before the cause is clarified and the amount is verified. Patients can legally sue the hospital, the manufacturer, or the holder of the marketing authorization, and have the right to choose. It is recommended to bring the medical records, imaging data, and device information to consult a professional lawyer to evaluate the evidence of defects and the items that can be claimed, and to grasp the time limit for sealing and filing.

VI. Frequently Asked Questions

Q1: If the equipment defects caused my injury, can I sue the hospital or the manufacturer successfully?

There is a good chance of winning the lawsuit, but it is necessary to prove the "defect" and the "causality". According to Article 1223 of the Civil Code, if a patient is injured due to a defect in medical devices, he/she can claim compensation from the medical institution or the device manufacturer or the holder of the marketing authorization without having to first prove who is "at fault", because product liability imposes strict liability on the manufacturer, and the manufacturer bears the burden of proof for the defect. The difficulty lies in proving that the device is indeed defective rather than due to surgical operation or personal factors: it is necessary to seal the involved devices, retrieve product registration and quality inspection materials, and entrust medical damage or product quality appraisal to prove that the device does not meet safety standards or causes harm when used normally. If the hospital is at fault in the procurement and use of the device (such as failing to verify the qualifications or using expired devices), the patient can also claim compensation separately or concurrently based on the liability for medical damage. If the evidence is sufficient, the patient has a high chance of successfully claiming compensation.

Q2: If I want to make a claim, what evidence do I need to prepare?

The evidence revolves around the "defect - damage - causality" chain: First, medical records and surgical records, including preoperative notifications, surgical consent forms, and postoperative imaging, to prove the fact of implantation or use; Second, evidence of the involved devices, including product packaging, labels, registration certificate numbers, and batch numbers, and request the prompt sealing of the suspected defective devices; Third, evidence of damage, including review of imaging, diagnostic certificates, medical expense receipts, and disability status; Fourth, appraisal materials, applying for medical damage appraisal or product quality appraisal to clarify the defect and causality; Fifth, communication records, preserving evidence of negotiations with hospitals and manufacturers. Sealing medical records and devices is a crucial step. Delaying this process may result in evidence being overwritten or devices being disposed of, weakening the claim.

Q3: How much compensation can I get for this claim?

The scope of compensation is determined in accordance with Article 1179 of the Civil Code: medical expenses, nursing care fees, transportation costs, nutrition fees, hospitalization meal subsidies, and loss of income; if it constitutes a disability, compensation for assistive devices and disability compensation is provided; if it results in death, compensation for funeral expenses and death compensation is provided. Device defects often require secondary surgery to remove or replace them, as well as long-term rehabilitation, with medical expenses and nursing care fees accounting for a large proportion of the total. The amount of compensation depends on the disability rating, the duration of loss of income and nursing care, and the need for follow-up treatment. Medical expenses must be supported by receipts, while loss of income is calculated based on income and a certificate of loss of income. Disability compensation is calculated according to the disability rating and local resident income standards. Claims should be itemized and accompanied by supporting documents. If necessary, the cost of follow-up treatment should also be evaluated to avoid settlement amounts being lower than legal standards.

Q4: How long does it take from discovering the equipment problem to receiving compensation?

If the responsibility is clear, the hospital or manufacturer is willing to negotiate, and the disability is relatively minor, compensation may be reached within a few months; but device defects often require professional appraisal, and medical damage appraisal or product quality appraisal itself takes a long time, often more than half a year. If the negotiation fails and a lawsuit is filed, the first-instance ordinary procedure generally takes several months, and the corresponding time will be extended if appraisal is required. After the judgment, if the insurer refuses to pay compensation, enforcement will be necessary. Note the statute of limitations: for personal injury caused by medical damage and product defects, the general statute of limitations is three years, starting from the date when the victim knows or should have known that his rights have been infringed and the obligee's identity has been identified; but the device may have been removed or the medical records are approaching the retention period. It is more advantageous to seal and appraise the evidence as early as possible, and delaying it will increase the difficulty of providing evidence.

Q5: The hospital said that the device has a valid registration certificate, but I'm still not sure what to do. What should I do now?

Having a registration certificate does not mean there are no defects. The registration certificate only indicates that the product has passed the market access, but it cannot rule out manufacturing defects in individual batches, design flaws, or insufficient warnings. When hospitals use this to shift blame, patients should: first, request to seal the physical products of the involved devices and the information of the same batch to prevent them from being disposed of; second, retrieve the product manuals, warnings, and registration inspection standards to compare with the actual usage situation; third, apply for product quality appraisal or medical damage appraisal to determine whether there are defects and the causality with the damage by professional institutions. If the appraisal confirms the existence of defects, even with a registration certificate, the manufacturer shall still bear responsibility in accordance with Articles 1203 and 1223; if the hospital is at fault in the procurement and acceptance, use of the products, it shall also bear responsibility. If no agreement can be reached through negotiation, the patient may sue and apply to the court for appraisal, and the claim shall be supported by the appraisal conclusion.

This article is written based on the common judicial interpretation in the Beijing area. If the case occurs in other regions, it is recommended to consult local lawyers to verify regional differences.

If you are currently facing similar problems, it is recommended that you consult a professional lawyer as soon as possible with the relevant evidence materials, to avoid missing the statutory time limit. →Personal injury legal services·Beijing Henglu Law Firm

Disclaimer: This article is compiled based on the current effective laws and regulations and public adjudication rules, and is for general reference only. It does not constitute a formal legal opinion on specific cases. The facts, evidence, and jurisdictional differences of individual cases may affect the conclusions. If you encounter disputes, please consult a practicing lawyer in time.