Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Date of Enforcement Report 2/11/2015
Class lI:
PRODUCT
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 Number Z-1058-2015
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.
RECALLING FIRM/MANUFACTURER
Covidien LP (formerly Nellcor Puritan Bennett Inc.) on 1/12/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
418 units
DISTRIBUTION
Nationwide and Canada.
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