Alerta De Seguridad para Physiological monitoring systems, intensive treatment and short duration, by telemetry. Acuity Central Station Physiological Monitoring Station installed on workstations Sun Microsystems, Models: (1) Ultra 5, (2) Ultra 10 .. Serial numbers: (1) FW03140982 to FW04330603, (2) TW03049094 to TW03049286; units manufactured from July 2000 to November 2000.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Welch Ally Protocol Inc Div Welch Allyn Inc.

¿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
    303
  • Fecha
    2001-10-05
  • País del evento
  • Fuente del evento
    ANVISA
  • 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 THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The central monitoring stations above may have locks on the cpu. during cpu blocking, the following occurs: (1) the acuity software screen freezes and no interaction with it is possible. (2) a small white console window appears on the screen. (3) an error message appears in the window indicating that a crash occurred on the cpu. (4) a prompt indicating ¿ok¿ appears, instructing the user to use the ¿go¿ key; however, acuity software does not allow the user to use this required action. the manufacturer initiated the correction by means of a letter dated june 1, 2001.
  • Acción
    Verify that you received the correction letter and the response card dated June 1, 2001, submitted by Welch Allyn. The company recommends the following: (1) Disconnect the affected CPU from the main power switch located behind the CPU near the power cord input. Wait for at least 10 seconds before turning it on again. The Acuity software will restart automatically. (2) If the Acuity software system is equipped with a high availability system, follow the internal procedure of your equipment to power it back up for backup. This usually involves switching the A / B switch from the video to position B and using the respective backup of the CPU and trackball. This will allow high CPU availability to have primary control of all monitoring functions. (3) If the high availability system is subject to a CPU crash, follow the same guidelines as described above by manually turning the key on after 10 seconds of waiting. (4) Report the above CPU failure to your local representative or directly to the Welch Allyn Technical Services Department at 1 (503) 526-8500 (in the United States). All affected Sun Microsystems workstations will be upgraded at no charge. Fill out the response card and return it to the Welch Allyn address. A Welch Allyn representative will contact you to help you resolve this problem. For more information, contact your local representative or directly with the Welch Allyn Technical Services Department from 8:00 AM to 5:30 PM (local time in the United States, please remember that it is 3 hours less than Brazil) by phone 1 (503) 526-8500.

Manufacturer