In recent years, the main reasons for the recall of infant incubator products are as follows: First, the depth of some drill holes is too deep, which causes the infusion stand assembled on the product to fall off; second, overheating of the power cord may cause the power cord and the Fire, scorch, smoke or sparks at the wall socket connection, and cause thermal damage; third, it is incorrectly set to skin temperature mode to preheat without patients, and for such misoperations, products There is no relevant risk warning in the manual; fourthly, the missing parameters of the test parameters of the product's factory test report are missing; fifthly, the "heating body" screw may loosen and fall to the bed after prolonged use, which may cause the risk of thermal damage to the patient.
References and data analysis of the more common adverse events of this type of products can find that the following problems are likely to occur in infant incubators:
The first is chaotic external markings, missing warning signs, substandard indicators and buttons, and substandard sockets-which may lead to incorrect operation by physicians, resulting in too high or low oxygen concentrations, inaccurate temperature control, high temperature burns to operators, and long babies. Time is placed in an overheated environment, causing health risks.
The second is the mode change after the power supply is interrupted. After the power supply is restored for a short time, if the temperature value of the incubator is changed, the baby may be left in an inappropriate temperature environment for a long time due to the doctor's failure to detect it in time. Health risks.
The third is that the skin temperature sensor is out of specification-it may lead to inaccurate measurements of the child's body temperature, which will mislead the doctor to place the baby in an inappropriate temperature environment for a long time, causing health risks.
Fourth, the alarm is out of specification-it may cause the baby to be placed in an inappropriate temperature environment for a long time, causing health risks.
Fifth, the temperature control is not accurate-it may cause the baby to be placed in an inappropriate temperature environment for a long time, causing health risks.
In terms of quality control, the following risk points should be focused on: 1. Whether the raw material inspection, semi-finished product or intermediate product inspection and product factory inspection procedures and inspection records are in accordance with product control regulations, quality standards and product technical requirements. Only in strict accordance with the quality control requirements of the product intermediate control, factory control, can effectively control non-conforming products. 2. Whether the instruments and equipment have reasonably formulated calibration or verification requirements and performed calibration or verification, especially some equipment may have mandatory verification requirements. 3. Control of non-conforming products. During the process of intermediate product testing and finished product testing, control the found non-conforming products, and handle them according to the program files, keeping the file records.