Events

Alerte De Sécurité sur Vital Matrix Monitors Press Mate Advantage: (1) Model 9861, (2) Model 9871. Serial numbers. 310004 to 311135

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 Colin Medical Instruments Corp.

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
    315
  • Date
    2001-10-26
  • 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 vital signs monitors above may exhibit erroneous breathing level and cause false alarm or non-functioning of the alarm. the manufacturer initiated the correction by letter dated april 3, 2001.
  • Action
    Check receipt of the letter dated April 3, 2001 from Colin Medical Instruments. Identify the isolate all affected products in your inventory. The company claims that approximately 80% of this correction was complete on October 16, 2001. This correction should be finalized on November 30, 2001. For more information, contact your local representative. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send by fax 0xx61-4481257

Device

Vital Matrix Monitors Press Mate Advantage: (1) Model 9861, (2) Model 9871. Serial numbers. 31000...

Manufacturer

Colin Medical Instruments Corp
  • Source
    ANVSANVISA