Events

Alerte De Sécurité sur AIRCAST COMPRESSION UNITS OF THE VENAFLOW SYSTEM

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 AIRCAST 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
    95
  • Date
    2001-06-30
  • 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
    Ecri reports that during the inspection of 125 venaflow systems compression units, 15 units presented ground resistance exceeding the limited limited 0.5 by the standards of the national fire protection association in health establishments, the us national fire protection associations standard for health care facilities (nfpa 99). ecri realized that various of the 15 replacement units also presented the same ground resistance problem. the manufacturer has developed a correction to the problem and adjusted all units that presented this failure, without any cost. ecri reports that revised units present ground resistance of <0.2.
  • Action
    ACTION REQUIRED: (NOTE: PLEASE READ THE ORIGINAL REPORT BELOW TO UNDERSTAND THE REASON BEYOND THE FOLLOWING RECOMMENDATIONS.) ECRI RECOMMENDS THAT HOSPITALS CONTINUE TO MONITOR GROUND RESISTANCE MEASUREMENTS FOR COMPRESSION UNITS OF VENAFLOW SYSTEMS OF AND RETURN ANY UNIT FOR THE COMPANY FOR A FREE REVIEW AND CORRECTION, IF THE GROUND RESISTANCE EXCEEDS 0.5 OR INCREASES PROSPELY OVER TIME. FOR FURTHER INFORMATION, PLEASE CONTACT KEN OLBRISH, ECRI, BY PHONE (610) 825-6000, RAMAL 5527.

Device

AIRCAST COMPRESSION UNITS OF THE VENAFLOW SYSTEM

Manufacturer

AIRCAST INC
  • Source
    ANVSANVISA