Safety Alert for Trade name: Efficia Vital Signs Monitor. Technical Name: Vital Signs Monitor. ANVISA registration number: 10216710305. Risk class: III. Model affected: CM120, CM150. Serial numbers affected: CM120: CN44701077 to CN62614750. CM150: CN50401316 to CN62609331

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.

Since the intended use of the monitor is intended for healthcare establishments under the supervision of qualified users (hospital staff), the use of monitors should be discontinued until the software is updated to eliminate the problem. If it is necessary that they be kept in use for a period of time, we recommend that the monitors be monitored constantly to identify if the monitor is faulty to trigger the apnea alarm. Customers who own these monitors will receive an information letter. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 02/28/2017 - Date of notification notice to Anvisa: 07/21/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "