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.
FDA Recall Z-1058-2015 · Posted 2015-02-05
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Recalling FirmCovidien LP (formerly Nellcor Puritan Bennett Inc.)
Recall StatusTerminated
Product CodeCBK
Date Initiated2015-01-12
Date Terminated2016-01-06
Product Quantity418 units
Reason for Recall
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Firm Action
Covidien sent an Urgent Field Safety Notice on January 12, 2015, to all affected customers. Customers were requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Covidien is updating software that will modify ventilator alarms and status display messages during a GUI reset. The Puritan Bennett 980 Ventilator Operator Manual will be updated to delete,replace ventilator during a GUI transient reset, and to inform users to monitor the secondary status display until the primary display refreshes. Covidien will communicate with customers when the software and operator manual updates are available.
Customers with questions were instructed to contact Technical Support Department at 800-255-6774, option 4, and then option 1.
For questions regarding this recall call 303-876-8870.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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