# K131252: Puritan Bennett 980 Series Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 24, 2014 after 298 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 6 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K902859 (1991). 77 ancestors in all.
2 later devices descend from it; 1 cites it directly.
10 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092847: 840 Ventilator System with Expanded Neomode Option, Covidien, Formerly Nellcor Puritan Bennett, Inc. (2010) Summary page 2.
- K103211: Avea Ventilator, Care Fusion (2011) Summary page 2.

## Most influential descendants
- K162738: Puritan Bennett 980 Ventilator System (2017), 1 descendant of its own
- K193056: Puritan Bennett 980 Series Ventilator System (2020), 0 descendants of its own

## Recalls of this device
- Nov 21, 2017 · Class II · Z-1208-2018: Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
- Jan 15, 2016 · Class II · Z-1181-2016: Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field
- Jul 16, 2015 · Class I · Z-2329-2015: 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 respira
- Jan 12, 2015 · Class II · Z-1058-2015: Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
- Oct 1, 2014 · Class I · Z-0112-2015: A software issue may lead to ventilator inoperative situations.
- Oct 1, 2014 · Class I · Z-0180-2015: Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.

## Indications for use
The Puritan BennetTM 980 Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory 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.

Source page: https://510kreport.com/device/K131252
Methodology: https://510kreport.com/methodology