Events

Safety Alert for Acuity Central Physiological Monitoring Station with the following software versions: (1) 4.03.00, (2) 4.03.01, (3) 4.03.02, (4) 4.03.03, (5) 4.03.04, (6) ) 4.03.05; (7) VHF / UHF protocol, wireless, telemetry units.

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
    305
  • 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
    These central monitoring stations installed with one of the software versions mentioned above and used with the above listed telemetry units operate inconsistently with the documentation found in the acuity system reference guide when the reset function is activated during the equipment's alert state . by activating the reset function during the machine's alert period, the border and icon on the screen will turn green. they should be blue. the manufacturer initiated the correction by letters dated march 13, 2001 and june 18, 2001, as well as by telephone dated june 18, 2001.
  • Action
    Check for letters and response cards dated March 13 and June 18, 2001, and the call dated June 18, 2001 from manufacturer Welch Allyn. Identify and isolate all affected products in inventory. Welch Allyn recommends the following: (1) Do not activate the reset function during the machine's alert period. Do not activate the suspend alarm function, which will cancel the buzzer for 90 seconds. (2) Check patient and activity, confirming patient position and cause of equipment alert period. (3) Indicate the cause of loss of communication (eg change the battery). (4) Disconnect all patients before they leave the monitoring area (for example: "net-off" or disconnect the telemetry). (5) Follow the instructions associated with remote control monitoring in the Acuity System Reference Guide (PN # 810-0961-00, Rev A, 2/98) and the Telemetry, Telemetry, Wireless, Reference (PN # 810-0548-02, Rev A, 10/96). Welch Allyn will provide an upgrade of the software at no charge. With it, when the reset function is activated, the audible alarms will be permanently suspended and a blue icon representing the disconnected patient will be generated. The blue icon and border will then change to green when data transmission is restored. Fill out and mail the reply card to Welch Allyn at the address mentioned in the mail. For more information, contact your local representative or directly with the technical service department from 8:00 a.m. to 5:30 p.m. by calling 1 (503) 526-8500 (in the United States).

Device

Acuity Central Physiological Monitoring Station with the following software versions: (1) 4.03.00...

Manufacturer

Welch Ally Protocol Inc Div Welch Allyn Inc
  • Source
    ANVSANVISA