Alerta De Seguridad para MONITOR OF DIXTAL VITAL SIGNS. Anvisa Registration n ° 10293490035. Models at risk: Family monitors 2020 (DX2020, DX2021 and DX2023), with software versions SBMAME5Kr20 and SBMAME5Kr19.

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.

Family 2020 monitors (DX2020, DX2021 and DX2023) were identified that restarted during normal use without operator interaction. The reset time lasts about 1 minute and 40 seconds, during which time the monitor does not perform any monitoring or alarm with the patient. On return, the alarm settings are maintained, and the monitor returns to normal operation. This reset, when it occurs, has no set frequency, and may occur within minutes or hours. The cause is in a part of the SBMAME5Kr20 software version code. The conditions that lead the equipment to arrive at this part of the software is not completely defined, and therefore, the company has taken a conservative approach to all products that may present the problem, which are the 233 monitors that have been updated in the field with this version software. There is no evidence, however, that all 233 devices with this release have presented or will fail, but all must have their version updated. Even when there is a low probability of real harm to the patient, when the risk analysis was performed, it was considered that the situation in the field was not acceptable due to the possibility of a more critical situation simultaneously with the time the product can stop monitoring the patient ( 1 minute and 40 seconds), so a mandatory field action has been defined for all products that may present the problem. If the product is used in this situation and the patient has an intercurrent such as cardiac or respiratory arrest during the equipment restart period, intervention and treatment by the hospital's medical staff may be delayed by about 1 minute and 40 seconds, when the alarms would come back to work and attract the attention of the user. As the intended use of the monitor is only in health facilities under the supervision of qualified users (hospital staff), the recommendation is that the use of the monitors should be discontinued immediately and be directed to the necessary corrective maintenance. If it is necessary that they be kept in use for a period of time, it is recommended that these monitors be constantly monitored to identify if the monitor is restarting and, in this case, that the patient is observed directly. Customers with these monitors will receive an informative letter from the company - also available at http://portal.anvisa.gov.br/wps/wcm/connect/5c85be00497425899c679eaccafa2755/Note+of+Aviso+DEDF1527.pdf?MOD=AJPERES. #### UPDATE (09/30/2015): Included software version SBMAME5Kr19 among products at risk.