Events

Alerte De Sécurité sur FANS USED IN INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) VIP GOLD, (2) VIP STERLING

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 BIRD PRODUCTS CORP SUB THERMO ELECTRON 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
    84
  • Date
    2001-02-02
  • 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 alarm failure risk is alert on the fans. these fans may not detect the pressure changes in accidental cases of extinguish or disconnect between the flow tubes for the child and the "sensor" interface. this occurs when the flow sensor to the child remain connected to the circuit. these fans may also fail to impose respirators when used with the sensor in tcpl simv mode, programmed for low assistance sensitivity. the manufacturer began this correction in letter of 28 september 2000.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE IBRD CORRECTION NOTIFICATION LETTER ON SEPTEMBER 28, 2000, REGARDING THE CPUS A, BE MONITOR OF VOLUME; INSTALLATION INSTRUCTIONS AND BIRD PRODUCTS VERIFICATION SHEET. IDENTIFY AND ISOLE THESE PRODUCTS. AGENDE WITH THE IBRD TECHNICAL SERVICE TO COME TO YOUR ESTABLISHMENT TO CHANGE THE CPUSES OF EACH OF THESE FANS. THEN COMPLETE THE CHECK FORM AND RETURN IT TO THE IBRD, ADJUSTMENT DEPARTMENT, BY FAX (0021-1-760-778-7274) OR BY MAIL (TO ADDRESS: 1100 BIRD CENTER DR, PALM SPRINGS CA 92262-8099 USA ). FOR FURTHER INFORMATION CONTACT YOUR IBRD OR TELEPHONE REPRESENTATIVE (0021-1-760-778-7200)

Device

FANS USED IN INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) VIP GOLD, (2) VIP STERLING

Manufacturer

BIRD PRODUCTS CORP SUB THERMO ELECTRON CORP.
  • Source
    ANVSANVISA