Events

Safety Alert for GIRAFFE OMNIBED CHILDREN INCUBATOR / RADIANT HEATING UNIT

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

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
    62
  • Date
    2001-05-14
  • 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
    Variation occurring oxygen concentrations may result in excessive or very insufficient exposures when units are operated in the incubator mode. the variations arise from the changes in the fan speed when the units are operated in the incubator mode and the oxygen flow is administered as free. changes in fan speed may cause bed temperature or intentional operator activation. ohmeda medical affirms that there was no report of aggravation due to variations in the oxygen concentration. (1) oxygen flow is administered as free, (2) no use of oxygen control system, and (3) patient oxygen saturation is not checked. the manufacturer started the safety alert with a dated letter of 28 february 2001.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE OHMEDA LETTER OF FEBRUARY 19, 2001, WITH A PRE-PAYMENT FORM FOR ANSWER AND WITH THE PAGES TO REPLACE IN THE OPERATION AND MAINTENANCE MANUAL. IDENTIFY ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN THE ESTABLISHMENT OF THE ALERT WITH THESE MACHINES. TO CONTINUE TO USE THESE MACHINES SAFELY, OHMEDA RECOMMENDS: (1) USE ONLY WITH CONTROL-SERVER SYSTEM FOR FREE-FLOW OXYGEN ADMINISTRATION WITHIN THE CHILD'S COMPARTMENT. (2) REPLACE PAGES 3-7 AND 3-8 (SAME SHEETS, OPPOSITE SIDES) IN THE OPERATION AND MAINTENANCE MANUAL WITH THE PAGES THAT WERE SENT WITH THE ALERT LETTER, REMOVE ORIGINALS AND DESTROY THEM. (3) ON EACH UNIT, REMOVE THE ORIGINAL OXYGEN ALERT WARNING LABEL AND REPLACE THEM FOR THE SELF-COLLIER THAT HAS BEEN SENT TO YOU, ACCORDING TO THE GUIDELINES PROVIDED WITH THE LETTER. IF YOU ARE A SELLER OR DISTRIBUTOR TO OTHER PLACES, SEND A COPY OF THE NOTIFICATION LETTER AND ANSWER TO CONSUMERS. IF YOU NEED MORE COPIES OF THE LETTER CONTACT THE OHMEDA SECURITY ALERTS COORDINATOR BY PHONE 00XX1-410-888-5213. COMPLETE AND RETURN THE RESPONSE TO OHMEDA TO THE INDICATED ADDRESS (OHMEDA MEDICAL AN INSTRUMENTARIUM CO., 8880 GORMAN RD, LAUREL MD 20723 USA).

Device

GIRAFFE OMNIBED CHILDREN INCUBATOR / RADIANT HEATING UNIT

Manufacturer

OHMEDA MEDICAL
  • Source
    ANVSANVISA