BEUDAMED
    FDA Enforcement Class II Terminated

    Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is 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). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs) "Assist/ Control, SIMV or Spontaneous modes of ventilation.

    Recall: Z-1058-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1058-2015
    Event ID
    70239
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    January 12, 2015
    Classification Date
    February 5, 2015
    Termination Date
    January 6, 2016
    Address
    6135 Gunbarrel Ave, N/A, Boulder, CO, 80301-3214, United States

    Description

    Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is 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). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs) "Assist/ Control, SIMV or Spontaneous modes of ventilation.

    Reason

    Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.

    Code Info

    All Puritan Bennett 980 ventilators

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada.

    Quantity

    418 units