Events

Recall of ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Resmed Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37832
  • Event Risk Class
    Class 2
  • Event Number
    Z-1006-2007
  • Event Initiated Date
    2007-04-23
  • Event Date Posted
    2007-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51799
  • Notes / Alerts
    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.
  • Extra notes in the data
    Flow Generator - Product Code BZD
  • Reason
    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
  • Model / 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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Canada, and Mexico.
  • Product Description
    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
  • Manufacturer Address
    Resmed Corporation, 14040 Danielson St, Poway CA 92064-6857
  • Source
    USFDA