Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Welch Ally Protocol Inc Div Welch Allyn Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    304
  • Date
    2001-10-05
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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.
  • Action
    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.

Device

Physiological monitoring systems, intensive treatment and short duration, by telemetry. Acuity Ce...

Manufacturer

Welch Ally Protocol Inc Div Welch Allyn Inc
  • Source
    ANVSANVISA