BEUDAMED
    FDA Enforcement Class I Terminated

    Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).

    Recall: Z-2329-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2329-2015
    Event ID
    71675
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    July 16, 2015
    Classification Date
    August 14, 2015
    Termination Date
    June 2, 2016
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214, United States

    Description

    Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).

    Reason

    Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.

    Code Info

    PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.

    Quantity

    657 units