Events

Retiro De Equipo (Recall) de Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant Warmers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fisher & Paykel Healthcare 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-2014-RN-01188-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-06
  • 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-2014-RN-01188-1
  • 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
    Fisher & paykel healthcare is issuing this recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
  • Acción
    Fisher & Paykel Healthcare is providing replacement nut to support the heater head and prevent falling.

Device

Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant Warmers
  • Modelo / Serial
    Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant WarmersModel Numbers: IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX & IW980XXXSerial Numbers: 071116ZZZZZZ to 090810ZZZZZZSpare Parts:Model Numbers: 043041129, 043041130, 043041131, 043042359, 648040142Lot Numbers: 071116 - 090810 (all spare parts) ARTG number: 100660
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd