Events

Alerte De Sécurité sur Phototherapy units, visible light, for hyperbilirubinemia Children's heating systems with phototherapy option 8004/8010 Dr <umlaut> ager Babytherm Catalog codes: FR00098, FR00104, FR00105, FR00114, FR00120, 2M30404

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 Draeger Medical Inc; Draeger Medizintechnik GmbH.

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
    318
  • Date
    2001-10-26
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Systems for infant hyperthermia have plastic cable connectors that can become brittle and break during the time of use. pieces of these broken connectors may fall from the radiation heater above into the babytherm mattress.
  • Action
    Please verify receipt of the letter and the response card dated March 9, 2001 from Draeguer Medical. Draeger Medical recommends that the Babytherm 8004/8010 mattress area be inspected immediately for pieces of plastic that may have fallen from the radiation heater located directly above the mattress. Draeger Medical claims that if the cable connectors become brittle and break, moving the unit can cause more breakage and falling of the pieces. All consumers must complete and return the reply card by mail at the address of the distributor above. DraegerService will contact you to arrange the replacement of plastic cable connectors with metal clips. The manufacturer has initiated a correction by letter dated March 9, 2001. For more information, contact your local Draeger Medical representative.

Device

Phototherapy units, visible light, for hyperbilirubinemia Children's heating systems with phototh...

Manufacturer

Draeger Medical Inc; Draeger Medizintechnik GmbH
  • Source
    ANVSANVISA