Events

Safety Alert for Intensive Care Ventilator Engstrom Carestation, Risk Class III, Model: Engstrom Carestation and Engstrom Pro, Brand: GE Healthcare, Registered: 80071260230, Serial Number: Engstrom CBCN01062 to CBCQ01396 (SEE APPENDIX). Accessory trolleys sold separately from Engstrom fans are also affected from October 2009 to September 2011.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil; DATEX-OHMEDA 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
    1519
  • Date
    2015-02-04
  • 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
    According to the record holder, failure of the caster assembly equipment may result in fan drop / tilt (imbalance).
  • Reason
    The company informs that specific combinations of engstrom fan casters and bases have been identified that are more likely to fail the caster mounting equipment. failure of the caster mounting equipment may result in fan dropping / tilting (imbalance). a fall / tilt of the engstrom fan may result in serious injury to patients or clinic staff.
  • Action
    GE Healthcare of Brazil makes it clear that customers can continue to use the Engstrom fan equipment. If the fan equipment is mounted on a cart, make sure that the carriage assembly is fully tightened and shows no signs of damage. If there are signs of damage, contact the GE Healthcare service or your local service representative. GE Healthcare will fix all affected systems at no cost to the customer. A GE Healthcare Technical Services representative will contact you to perform this fix. (SEE CUSTOMER LETTER)

Device

Intensive Care Ventilator Engstrom Carestation, Risk Class III, Model: Engstrom Carestation and E...

Manufacturer

GE Healthcare do Brasil; DATEX-OHMEDA Inc.