Events

Retiro De Equipo (Recall) de INVACARE PEDIATRIC FLOWMETER ACCESSORY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INVACARE CORPORATION.

¿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
    109777
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The rear gradation scale was screen printed upside down on the flowmeter gauge. proper delivery of oxygen is critical to infants. in the population at greatest risk i.E. pediatric population health impact specific to high oxygen saturation could result in systemic toxicity potential lung vascular injury or over extended period of time could cause blindness.

Device

INVACARE PEDIATRIC FLOWMETER ACCESSORY
  • Modelo / Serial
    Model Catalog: IRCPF16AW (Lot serial: 16BF017557); Model Catalog: IRCPF16 (Lot serial: 16BF017557); Model Catalog: IRCPF16AW (Lot serial: 16DF040094); Model Catalog: IRCPF16 (Lot serial: 16DF040094); Model Catalog: IRCPF16AW (Lot serial: 16CF040083); Model Catalog: IRCPF16 (Lot serial: 16CF040083); Model Catalog: IRCPF16 (Lot serial: 16CF040071); Model Catalog: IRCPF16 (Lot serial: 16CF030121); Model Catalog: IRCPF16AW (Lot serial: 16CF030112); Model Catalog: IRCPF16 (Lot serial: 16CF030112); Model Catalog: IRCPF16AW (Lot serial: 16CF032024); Model Catalog: IRCPF16 (Lot serial: 16CF032024); Model Catalog: IRCPF16AW (Lot serial: 16CF040071); Model Catalog: IRCPF16AW (Lot serial: 16CF030121)
  • Descripción del producto
    INVACARE PRECISE RX PEDIATRIC FLOWMETER
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION