Device 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.
Z-1058-2015
Product summary
- Event
- Event 70239
- Status
- Terminated
- Classification
- Class II
- Quantity
- 418 units
- Official record key
device-enforcement:Z-1058-2015
Official wording
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 information: All Puritan Bennett 980 ventilators
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Derived failure modes
-
Unknown
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.