Events

Alerta De Seguridad para Pulse Oximeter M1000; Registration 10349590038; Risk Class: III; Model M1000; Lot: 26461: Serial numbers affected: 13400338, 13400339; 13400341, 13400342, 13400343, 13400344, 13400344, 13400346, 13400347, 13400348, 13400349, 13400350, 13400351, 13400352, 13400353, 13400354, 13400355, 13400356, 13400357, 13400358, 13400359, 13400360, 13400361, 13400362, 13400363, 13400365, 13400366, 13400367, 13400368; 13400369 and 13400370.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por J. G. Moriya Representação Importadora Exportadora e Comercial Ltda.

¿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
    1797
  • Fecha
    2016-01-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The company will include the improvements pointed out in the assembly process of the new equipment. Three possible situations that could fail were pointed out: transportation, battery discharge and lack of information attached to the product. These items can impair your operation.
  • Causa
    Equipment does not turn on due to the flat cable of the membrane keyboard being "loose"; equipment does not operate the battery because the battery connectors are "loose"; padded membrane keyboard; does not read spo2.
  • Acción
    Field correction of equipment. Action code: 25500. The company will make the correction in the field pointing out the following changes: be more demanding with the receipt of oximetry sensors and signal cables. / / The connectors of the cables that attach to the terminals of the battery are now totally isolated and tighter to the terminals, preventing it from loosening during transport. / / The front plate has won welded screws for better positioning and good fixation of the display.// The flat cable of the keyboard is now fixed to the connector 2 of the board with a tape adhesive to prevent it from loosening during transport due to the weight of the ferrite. / / Start the battery autonomy tests during the assembly process and check if the battery maintains the load duration equal to or greater than specified. a "battery charge" label on the top cover of the case pointing to the "ON / OFF" switch, to alert the user to keep the "on / off" switch of the connected equipment, so s maintaining the battery recharged. / / Elimination of excess of the membrane to fit fit to the assembly.

Device

Pulse Oximeter M1000; Registration 10349590038; Risk Class: III; Model M1000; Lot: 26461: Serial ...

Manufacturer

J. G. Moriya Representação Importadora Exportadora e Comercial Ltda