Events

Alerte De Sécurité sur Trade name: Heated Cradle Technical Name: Ohmeda Heated Cradle ANVISA Registration Number: 10265410005 Hazard Class: II Affected Model: 2001, 3000, 3050, 3100, 3150, 3300, 3400, 3500, 4000, 4300 or 4400 Serial numbers affected : Check photos made available on the Urgent Security Notice letter which differentiate products at risk from those that have not been affected.

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

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
    2137
  • Date
    2016-08-26
  • 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
    If "Heater Head" maintenance has been performed in the past, check to make sure the bolts are tight as soon as the unit becomes available. If the "Heater Head" assembly has not been serviced, check to make sure the bolts are tight as part of your next regular annual Preventive Maintenance check. The Service Manual Addendum provides instructions for checking and tightening the bolts. During each annual Preventive Maintenance check, continue to make sure the bolts are tight. The Addendum to the Services Manual will be delivered together with the Urgent Security Notice letter. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Cause
    Hot heater head screws on the heated crib may fall on the bed if the "heater head" assembly has been improperly serviced. this situation may be clinically dangerous as it may result in thermal injury to the patient. two lesions were reported as a result of this problem. the possibility of this problem occurring will only be present if the "heater head" assembly has been subjected to improper maintenance.
  • Action
    Field Action Code IMF 32047 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company shall deliver a letter of Urgent Security Notice and Addendum to the Services Manual.

Device

Trade name: Heated Cradle Technical Name: Ohmeda Heated Cradle ANVISA Registration Number: 102654...

Manufacturer

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