# K193056: Puritan Bennett 980 Series Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Nov 20, 2020 after 385 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 17 (17 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K902859 (1991). 79 ancestors in all.
No later device cites it as a predicate yet.
10 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162738: Puritan Bennett 980 Ventilator System, Covidien (2017) Summary page 4.

## Recalls of this device
- Mar 25, 2022 · Class I · Z-0966-2022: The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment
- Nov 4, 2021 · Class I · Z-0345-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0350-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0346-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0349-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0351-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0338-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0339-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0340-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0343-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0344-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0353-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0341-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0342-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0347-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0348-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Nov 4, 2021 · Class I · Z-0352-2022: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

## Indications for use
The Puritan Bennett 980 Series 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 0.3kg (0.661b). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively to patients who require the following types of ventilator support - Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or non-invasively (via mask or nasal prongs) - Assist/Control, SIMV, or Spontaneous modes of ventilation

Source page: https://510kreport.com/device/K193056
Methodology: https://510kreport.com/methodology