OBJECTIVE: To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use. METHODS: The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events. RESULTS: During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%. CONCLUSION There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
Blood Transfusion/instrumentation* ; Risk Factors ; Quality Control ; Humans ; Risk Management ; Equipment Failure

OBJECTIVE: To enhance the reliability of medical equipment, this study aims to develop a failure cause diagnosis model and provide rational suggestions for efficient equipment use. METHODS: Combine fault tree analysis (FTA) to identify basic events causing equipment failure and calculate their prior probabilities. Obtain conditional probability tables for each node through expert assessment. Integrate triangular fuzzy number theory with Bayesian network (BN) to construct a fuzzy Bayesian network (FBN) for posterior probability inference and sensitivity analysis. RESULTS: Using endoscopes as the subject, the analysis shows that the model accurately calculates the endoscope failure probability at 0.385%, and identifies the key causes: improper cleaning ( X5, posterior probability 0.36064), untimely fault detection ( X8, posterior probability 0.23571), irregular transportation ( X6, posterior probability 0.11344), and natural aging ( X10, posterior probability 0.11377). Sensitivity analysis also confirms their influence weights (mutual information values are 0.00749, 0.00591, 0.00202, 0.00174). CONCLUSION The model can accurately perform quantitative analysis and rapid fault location of medical equipment failures, enabling effective preventive measures.
Bayes Theorem ; Fuzzy Logic ; Equipment Failure Analysis/methods* ; Equipment Failure ; Algorithms

Peritoneal dialysis (PD) is one of the main renal replacement therapy methods for patients with end-stage chronic kidney disease, and peritoneal dialysis belt is a key auxiliary device. However, there are some problems in the existing PD technology, such as the separation of heating system and dialysate system, the inability to continuously heat dialysate and the single function of peritoneal dialysis belt. In order to solve the above problems, the staff of Shanghai Geriatric Medical Center designed an intelligent temperature-controlled peritoneal dialysis belt and obtained the National Utility Model Patent of China (patent number: ZL 2023 2 1815961.9). The intelligent temperature-controlled peritoneal dialysis belt is composed of a double-layer fixed belt, an intelligent temperature control system (including temperature control structure and intelligent control system) and other auxiliary structures. The peritoneal dialysis tube can penetrate into the dissection from the entry of the inner surface of the fixed belt and pass through the exit of the outer surface. The double-layer fixed belt ensures the stable fixation of the dialysis tube. The two ends of the fixing belt are designed with magic stickers to adjust the tightness of the fixing belt to adapt to people with different waist circumferences. The interlayer is equipped with an intelligent temperature control system, which can continuously heat the dialysate through an electric heating plate to maintain a temperature close to the body temperature. Through the display screen and controller on the intelligent control system, medical staff can be allowed to monitor and adjust the temperature, pressure and flow parameters of the dialysate in real time. In addition, a cloth with a pulling chain is designed on the inner surface of the fixed belt, and the cloth is opened to facilitate the medical staff to wear the peritoneal dialysis tube in the temperature control structure or the restraint belt. The intelligent temperature-controlled peritoneal dialysis belt enhances the effectiveness of PD, saves PD resources, improves the convenience of PD, is suitable for family and hospital use, can effectively improve the quality of life of patients with chronic renal failure, and is suitable for clinical promotion.
Peritoneal Dialysis/instrumentation* ; Humans ; Equipment Design ; Temperature ; Kidney Failure, Chronic/therapy* ; Dialysis Solutions

OBJECTIVE: To analyze the malfunction and maintenance process of Carestream digital X-ray machine DRX-NOVA for reference. METHODS: The fault of Carestream digital X-ray machine DRX-NOVA in 2011-2021 was summarized, the fault types were classified, and the maintenance process was summarized. RESULTS: Fault types can be divided into three categories, each of which has its own characteristics and specific solutions. CONCLUSIONS It is necessary to master the principle of equipment to repair all kinds of equipment failures. Repair the machine should be careful, comprehensive consideration of the cause of the failure. To correctly understand and analyze the operation of the machine under normal conditions, we can accurately analyze the cause of failure, so that we can really solve the problem.
X-Rays ; Radiography ; Radiographic Image Enhancement ; Equipment Failure

OBJECTIVE: To compare the performance of the GE cyclotron MINItrace system before and after the upgrade. METHODS: The upgrade of the MINItrace system included replacing the silver target with the Nb syetem and adopting the latest RF control and management system and lastest ion source system.The failrue rate and production efficiency were retrospectively analyzed before and after the upgrade. RESULTS: After the upgrade, the cyclotron failure rate decreased by 86.2%, the average capacity increased by 45%. CONCLUSIONS After the upgrade of MINItrace cyclotron, the failure rate is sharply reduced, and the production efficiency is grately improved.
Cyclotrons/standards* ; Equipment Failure ; Retrospective Studies

This paper is a summary of the three types of faults that have occurred in the recent years in the Carestream DR7500:hardware failure, software failure, and communication failure. The specific cases of three types of faults are introduced in a case-by-case basis.
Equipment Failure ; Maintenance ; Radiographic Image Enhancement

Epilepsy is one of the major chronic neurological diseases affecting many patients. Resection surgery is the most effective therapy for medically intractable epilepsy, but it is not feasible in all patients. Vagus nerve stimulation (VNS) is an adjunctive neuromodulation therapy that was approved in 1997 for the alleviation of seizures; however, efforts to control epilepsy by stimulating the vagus nerve have been studied for over 100 years. Although its exact mechanism is still under investigation, VNS is thought to affect various brain areas. Hence, VNS has a wide indication for various intractable epileptic syndromes and epilepsy-related comorbidities. Moreover, recent studies have shown anti-inflammatory effects of VNS, and the indication is expanding beyond epilepsy to rheumatoid arthritis, chronic headaches, and depression. VNS yields a more than 50% reduction in seizures in approximately 60% of recipients, with an increase in reduction rates as the follow-up duration increases. The complication rate of VNS is 3–6%, and infection is the most important complication to consider. However, revision surgery was reported to be feasible and safe with appropriate measures. Recently, noninvasive VNS (nVNS) has been introduced, which can be performed transcutaneously without implantation surgery. Although more clinical trials are being conducted, nVNS can reduce the risk of infection and subsequent device failure. In conclusion, VNS has been demonstrated to be beneficial and effective in the treatment of epilepsy and various diseases, and more development is expected in the future.
Arthritis, Rheumatoid ; Brain ; Comorbidity ; Depression ; Drug Resistant Epilepsy ; Epilepsy ; Equipment Failure ; Follow-Up Studies ; Headache Disorders ; Humans ; Seizures ; Transcutaneous Electric Nerve Stimulation ; Vagus Nerve Stimulation ; Vagus Nerve

OBJECTIVE: Improve the integrity of the digestive electron microscope equipment and reduce the cost of equipment failure maintenance. METHODS: By studying the composition and function of the digestive electron microscope system and analyzing the causes of common faults, a targeted preventive maintenance plan is developed, equipment users are graded, and a training system is established. RESULTS: The user of the device can skillfully analyze the cause of the malfunction and timely deal with the sudden failure of the diagnosis and treatment, thereby reduce the risk of diagnosis and treatment and the investment in hospital maintenance. CONCLUSIONS Through the analysis and processing of the digestive electron microscope system, point detection leakage, grading training, preventive maintenance can significantly improve the equipment integrity rate, reduce the risk of clinical diagnosis and treatment, effectively reduce the number of equipment failures, and reduce maintenance costs.
Equipment Failure ; Maintenance and Engineering, Hospital ; Microscopy, Electron ; instrumentation

OBJECTIVE: To explore the high-risk fault risk of CT simulator and the main causes of the risk, and to put forward effective risk management strategies. METHODS: The failure mode and effect analysis method was used to identify and control the operational fault risk of CT simulator. RESULTS: 5 major fault components, 8 fault failure models and 17 failure causes were analyzed. The top 5 failure causes are:anode target surface burn caused by direct scanning without warming up the tube (590.4), tube failure (518.2), burnout of joints caused by aging of high voltage cables (424.2), motor carbon brush wear (304.8) and belt break (296.4). CONCLUSIONS The failure mode and effect analysis method can effectively identify the risk of equipment failure, and thus specifically formulate risk management and control measures to ensure the normal operation of equipment and the safety of doctors and patients.
Equipment Failure ; statistics & numerical data ; Humans ; Risk Management ; methods ; Tomography, X-Ray Computed ; standards

An implantable axial blood pump was designed according to the circulation assist requirement of severe heart failure patients of China. The design point was chosen at 3 L/min flow rate with 100 mm Hg pressure rise when the blood pump can provide flow rates of 2-7 L/min. The blood pump with good hemolytic and anti-thrombogenic property at widely operating range was designed by developing a structure that including the spindly rotor impeller structure and the diffuser with splitter blades and cantilevered main blades. Numerical simulation and particle image velocimetry (PIV) experiment were conducted to analyze the hydraulic, flow fields and hemolytic performance of the blood pump. The results showed that the blood pump could provide flow rates of 2-7 L/min with pressure rise of 60.0-151.3 mm Hg when the blood pump rotating from 7 000 to 11 000 r/min. After adding the splitter blades, the separation flow at the suction surface of the diffuser has been reduced efficiently. The cantilever structure changed the blade gap from shroud to hub that reduced the tangential velocity from 6.2 m/s to 4.3-1.1 m/s in blade gap. Moreover, the maximum scalar shear stress of the blood pump was 897.3 Pa, and the averaged scalar shear stress was 37.7 Pa. The hemolysis index of the blood pump was 0.168% calculated with Heuser's hemolysis model. The PIV and simulated results showed the overall agreement of flow field distribution in diffuser region. The blood damage caused by higher shear stress would be reduced by adopting the spindle rotor impeller and diffuser with splitter blades and cantilevered main blades. The blood could flow smoothly through the axial blood pump with satisfactory hydraulics performance and without separation flow.
China ; Computer Simulation ; Equipment Design ; Heart Failure ; therapy ; Heart-Assist Devices ; Hemolysis ; Humans ; Models, Cardiovascular