BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1006-2007 · Initiated April 23, 2007

    Recall

    Recall Number
    Z-1006-2007
    Event Number
    37832
    Firm
    Resmed Corporation
    FEI Number
    1000115734
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 23, 2007
    Posted
    July 3, 2007
    Terminated
    December 6, 2010
    Address
    14040 Danielson St, Poway, CA, 92064-6857

    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.

    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.

    Distribution

    Worldwide, USA, Canada, and Mexico.

    Quantity

    300,000