Events

Rappel de ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Resmed Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37832
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1006-2007
  • Date de mise en oeuvre de l'événement
    2007-04-23
  • Date de publication de l'événement
    2007-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51799
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Flow Generator - Product Code BZD
  • Cause
    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).
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, USA, Canada, and Mexico.
  • Description du dispositif
    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
  • Adresse du fabricant
    Resmed Corporation, 14040 Danielson St, Poway CA 92064-6857
  • Source
    USFDA