Alerta De Seguridad para Commercial Name: Ultrasound System. Technical Name: Ultrasound Device. ANVISA registration number: 80372200002. Hazard class: II. Model affected: MyLab70 XVG; MyLab60; MyLab70 X Vision. Serial numbers affected: 1093; 1096; 1103; 1106; 1135; 1171; 1189; 1191; 1193; 1209; 1212; 1223; 1224; 1225; 1251; 1254; 1255; 1258; 1259; 1260; 1263; 1264; 1265; 1266; 1267; 1268; 1271; 1274; 1275; 1276; 1353; 1436; 1437; 1442; 1443; 1463; 1466; 1471; 1472; 1493; 1498; 1499; 1506; 1520; 1521; 1522; 1523; 1524; 1528; 1529; 153/01370; 153/01373; 153/01383; 1531; 1532; 1533; 1537; 1538; 1544; 1545; 1546; 1547; 1548; 1621; 1622; 1630; 1631; 1632; 1801; 1802; 1803; 1804; 1805; 1837; 1838; 1839; 1870; 1871; 1872; 2075; 2077; 2137; 2138; 2147; 860; 984; 985; 988; 991; 1341; 1512; 1582; 1588; 1604; 1605; 1757; 1783; 1791; 1824; 1830; 1985; 2096

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Anima Médica Comércio Importação e Exportação Ltda; Esaote S.p.A..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Until Customer receives and has installed corrective software update, Customer must refrain from using the PA023E probe in PW mode, or other mode combined with PW, such as B + PW, B + CFM + PW, in applications Pediatric, Pediatric Cardiac and Neonatal clinics. In Cardiac and Vascular applications, please monitor as much as possible any temperature increase on the contact surface of the Probe - if the patient reports any discomfort, immediately stop the procedure. As a general safety rule, it is recommended to use the probes in the default settings to keep the examination time as short as necessary to produce a useful diagnostic result and not keep the probes in a fixed position for longer than is strictly required. Distribute this alert to all appropriate employees in your organization and forward it to all users of these systems, including others to whom you have transferred the equipment - in this case, provide information to the registrant (Esaote) about the new owner of the device, to that the company can ensure the traceability of devices under risk. 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 Additional information: - Date of identification of the problem by the company: 19/01/2018 - Date of notification notice to Anvisa: 12/28/2017 The company that owns the affected product is responsible for contacting its customers in due time. 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. (...) "
  • Causa
    The power monitoring settings of the pa023e probe may not be effective when pulsed wave doppler (pw) is activated under specific operating conditions so that the probe's contact surface may overheat in about five minutes of continuous operations . the patient may experience discomfort, redness of the epidermis and / or mild pain.
  • Acción
    Field Action Code CAPA 200009703 triggered under the responsibility of the company Anima Médica Comércio Importação e Exportação Ltda. Will make product field correction.