Events

Safety Alert for Trade name: Heated Cradle Technical Name: Heated Cradle Lullaby ANVISA Registration Number: 80071260219 Hazard Class: III Model Affected: Heated Lullaby Cradle Serial numbers affected: Lullaby Heated Cradle (230V) and Lullaby Heated Cradle (115V). View the Product Images in the Urgent Security Notice Letter to check the images of Affected and Non-Affected products.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; WIPRO GE HEALTHCARE PRIVATE LTD; 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
    2136
  • Date
    2016-10-30
  • 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
    The user must ensure that the bolts are tight as soon as the unit becomes available and there are no patients in the bed. The Maintenance Manual Addendum, shipped with the Urgent Safety Warning Letter, provides instructions for checking and tightening the bolts. During each annual Preventive Maintenance check, the user must continue to make sure the bolts are tight. In addition, GE Healthcare provides instructions on how to correct the problem. You should add this new Addendum to the Maintenance Manual for your devices, and affected users should be trained accordingly. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Reason
    The "heater head" screws on the lullaby heated cradle may loosen over time and could fall into bed. this situation may be clinically dangerous because it may result in possible thermal injury to the patient.
  • Action
    Field Action Code IMF 32049 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company to deliver letter of Urgent Security Notice and Addendum to the Maintenance Manual

Device

Trade name: Heated Cradle Technical Name: Heated Cradle Lullaby ANVISA Registration Number: 80071...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; WIPRO GE HEALT...