Recall – Software update leads to GUI error

Company: COVIDIEN LLC
Date of Enforcement Report: 12/18/2018
Class I

PRODUCT

Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett” 980 Pediatric Adult Ventilator Puritan Bennett” 980 Neonatal Ventilator Puritan Bennett” 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator 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 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 followingtypes 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-0497-2019

REASON

Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation

RECALLING FIRM/MANUFACTURER

COVIDIEN LLC, Mansfield, MA on 9/18/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9,593

DISTRIBUTION
U.S. Nationwide and International

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.