Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Welch Ally Protocol Inc Div Welch Allyn Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    305
  • Date
    2001-10-05
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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