Events

Retiro De Equipo (Recall) de ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Resmed 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
    37832
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1006-2007
  • Fecha de inicio del evento
    2007-04-23
  • Fecha de publicación del evento
    2007-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51799
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Flow Generator - Product Code BZD
  • Causa
    S8 devices manufactured between july 2004 and may 15, 2006 are susceptible to fatigue in the connection of the ac appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke).
  • Acción
    ResMed began to broadly distribute information regarding the recall on 4/23/2007. A press release was issued on 4/23/2007 with information regarding the recall and information was posted at ww.resmed.com/s8program. The firm is providing a Consignee notification package and press release to include(1) specific device names subject to the recall and affected serial numbers; specific information to be provided in each package to the end-customer. The specific information to the end user customers will include: (1) specific device names subject to the recall; (2) affected serial numbers; (3)continuing use and safety information; and (4) contact information for requesting additional details. Patients are advised that they may continue to use their S8 flow generators until a replacement unit is provided. ResMed is instructing patients, sleep labs, and hospitals to continue using the device, placing it on a hard clean surface, with a clear area around the device. ResMed intends to replace the affected products with either a new device or a device in which the affected components have been replaced.

Device

ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator
  • Modelo / Serial
    Serial numbers for all S8 models: From 20040285613 to 20060269563; From 20060275728 to 20060276751; From 20060277160 to 20060277415; From 20060281672 to 20060281991; From 20060283424 to 20060283743; From 20060284896 to 20060285445; From 20060287568 to 20060290823; From 20060292360 to 20060294694; From 20060312361 to 20060312597; From 20060318692 to 20060319459; From 20060325074 to 20060327794; From 20060330588 to 20060331043.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, USA, Canada, and Mexico.
  • Descripción del producto
    ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.
  • Manufacturer
    Resmed Corporation

Manufacturer

Resmed Corporation
  • Dirección del fabricante
    Resmed Corporation, 14040 Danielson St, Poway CA 92064-6857
  • Source
    USFDA