Events

Safety Alert for AIRCAST COMPRESSION UNITS OF THE VENAFLOW SYSTEM

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AIRCAST INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    95
  • Date
    2001-06-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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