Paramount Motorized Bed. Model KA-6000. Anvisa Registry n ° 80102510312. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

According to the manufacturer of the product, the mentioned error is foreseen in product risk management and in the Equipment Instruction Manual, as well as corrective action (by the user of the product) to remedy the problem - removal of the power cable from the network for a few seconds and reconnect the device. According to the manufacturer, the error poses no risk to the safety of the patient or the operator, since it does not imply inadvertent movement of the device. After completing the investigative process in Brazil, conducted by the manufacturer of the product and by the registry holder, the root cause for the problem was the difference between the voltages in the electrical networks of the hospitals (127V) where the products are installed and the voltage of to which the product was designed (110V). This fact would be responsible for a greater occurrence of error code H01. The field action will consist of replacing part of the bed control boxes and the component called Hybrid Integrated Circuit - an integral part of the control boxes. According to the registry holder, the product at risk was distributed to only two hospitals in Brazil.