Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Draeger Medical Inc; Draeger Medizintechnik GmbH.

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
    318
  • Date
    2001-10-26
  • 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
    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