Events

Retiro De Equipo (Recall) de PERFECTO2

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
    29338
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-22
  • 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
    Invacare has learned that the psi (pressure sensitive interrupter) designed for the compressor motor start/run capacitor by one supplier could lead to rupture. that capacitor in the oxygen concentrator has an internal pressure relief component (the psi) which may not operate as intended permitting the capacitor to rupture in certain circumstances. if the psi does not function to relieve the heat and pressure due to a short circuit within the capacitor then the pressure can cause a rupture in the seam between the housing and the end plate. if the rupture occurs the oil may be expelled from the capcitor which may result in a fire hazard.

Device

PERFECTO2
  • Modelo / Serial
    Model Catalog: IRC9LXO2AWQN (Lot serial: 10FSZ470209); Model Catalog: IRC5PO2 (Lot serial: 10FSZ470209); Model Catalog: IRC5P (Lot serial: 10FSZ470209); Model Catalog: IRC9LXO2AWQN (Lot serial: 10HSZ470004); Model Catalog: IRC5PO2 (Lot serial: 10HSZ470004); Model Catalog: IRC5P (Lot serial: 10HSZ470004); Model Catalog: IRC9LXO2AWQN (Lot serial: 10ISZ470005); Model Catalog: IRC5PO2 (Lot serial: 10ISZ470005); Model Catalog: IRC5P (Lot serial: 10ISZ470005); Model Catalog: IRC9LXO2AWQN (Lot serial: 10ISZ470051); Model Catalog: IRC5PO2 (Lot serial: 10ISZ470051); Model Catalog: IRC5P (Lot serial: 10ISZ470051); Model Catalog: IRC9LXO2AWQN (Lot serial: 10CSZ43XXXX - 12GSZ62XXXX); Model Catalog: IRC5PO2 (Lot serial: 10CSZ43XXXX - 12GSZ62XXXX); Model Catalog: IRC5P (Lot serial: 10CSZ43XXXX - 12GSZ62XXXX)
  • Descripción del producto
    INVACARE PERFECTO2
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION