Events

Alerta De Seguridad para Escort Series E300 Breathing monitors and patient electrocardiography configured with Main Softwar Versions 7.68 and 7.69. (Patient Electrocardiograph and Respiration Monitors configured with Main Software Versions 7.68 and 7.69). No. Series N-Sequential: 1001 to 4086

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medical Data Electronics.

¿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
    220
  • Fecha
    2000-12-08
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The hyperventilation alarm on the top of the monitors may malfunction when this alarm is turned on if the monitor is turned off and on again. this action turns off the hyperventilation alarm, but causes the monitor to erroneously indicate that this alarm is triggered. all other unit alarms operate normally. the manufacturer initiated a mail-order withdrawal sent on july 6, 2000, followed by two subsequent phone calls to all service providers who use these devices to make sure the receipt and actions are taken by the providers.
  • Acción
    Make sure you have received the correspondence sent on July 6, 2000, (replacing the EPROM-erasable programmable read-only memory) with the software version 7.70, instructions for replacing the EPROM, and Installation Certificate, as well as telephone calls from Medical Data Electronics (MDE). Identify and collect any affected product from your inventory. Until the new program is installed, turn off the breath alarm, or change the Hyperventilation Limit function to re-enable the hyperventilation alarm. As soon as you receive the EPROM replacement program, install it and return the Installation Certificate immediately to the MDE by fax 1 (818) 768-0759 or by mail to the above address. For more information, contact your local representative or directly with MDE Technical Services at 1 (818) 768-6411 in the United States.

Device

Escort Series E300 Breathing monitors and patient electrocardiography configured with Main Softwa...

Manufacturer

Medical Data Electronics
  • Source
    ANVSANVISA