Events

Alerte De Sécurité sur Physiological monitoring systems, by telemetry. 18-inch flat-panel, touch-screen color LCD monitor for PatientNet, Visa and Visa II Central Stations. Part No. 0160-00-0059; Serial numbers: 01-9682, 01-9683, 01-9685, 01-9686, 01-9688, 01-9690, 01-9694, 01-9695, 01-9696, 01-9698, 01-9699, 01- 9700, 01-9703, 01-9704, 01-9901

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 Datascope Corp Patient Monitoring Div.

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
    324
  • Date
    2001-11-02
  • 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
    The above monitors may drop when a user attempts to tilt the top of the monitor to an angle that exceeds 5o forward or 45o backward relative to its vertical position. the monitor is not secure at the base. there is no associated risk to the patient, as long as the monitor is not installed in the vicinity of the patient; however, a greater risk of physical injury to the patient or to the user may exist when the monitor is maneuvered because it is in an unstable position, which can cause the monitor to drop. the manufacturer initiated the correction by letter dated june 28, 2001.
  • Action
    Please verify receipt of a letter dated June 28, 2001 from Datascope. Identify and isolate all affected products in your inventory. Your local Datascope representative will upgrade your monitor by adding a stabilization plate to its base that will prevent the unit from overturning. In addition, your operator's manual will be updated to alert the user to use a device at the base of the monitor if it is intended to tilt the monitor head more than 45o to prevent it from falling backwards. This work will be free. For more information, contact your local representative or directly with Datascope at 1 (201) 995-8237 in the United States.

Device

Physiological monitoring systems, by telemetry. 18-inch flat-panel, touch-screen color LCD monito...

Manufacturer

Datascope Corp Patient Monitoring Div
  • Source
    ANVSANVISA