BEUDAMED
    FDA Recall Terminated

    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.

    Recall: Z-0926-2014 · Initiated September 11, 2013

    Recall

    Recall Number
    Z-0926-2014
    Event Number
    67248
    Firm
    ArjoHuntleigh Inc.
    FEI Number
    3010048749
    Product Code
    IKZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 11, 2013
    Posted
    February 4, 2014
    Terminated
    January 8, 2015
    Address
    4958 Stout Dr, San Antonio, TX, 78219-4334

    Description

    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.

    Reason

    The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient

    Action

    ArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. For questions call 630-785-4885.

    Distribution

    US Nationwide and Middle East

    Quantity

    231 units