Events

Retiro De Equipo (Recall) de Nellcor RS10 SpO2 Forehead Sensor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01644-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01644-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Medtronic is recalling specific item codes and production lots of the covidien nellcor rs10 spo2 forehead sensor. this recall is being conducted due to a labelling error. the label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. the sensor array itself is latex free. the use of products containing latex may result in allergic reactions for patients and providers who have latex sensitivity. allergic reactions can include skin rash, itching, dyspnoea and anaphylaxis. there have been no reports of serious injury associated with this issue.
  • Acción
    Medtronic is advising users to quarantine and discontinue use of the affected item codes and lots. Also, immediately advise all surgeons/surgery personnel of this recall. Medtronic will be issuing credit for returned devices.

Device

Nellcor RS10 SpO2 Forehead Sensor
  • Modelo / Serial
    Nellcor RS10 SpO2 Forehead Sensor Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H, 161970090H, 162040107H, 162110103H, 162320191H and 162390212HARTG Number: 182876
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA