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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00089-1
Product Name/Description	Puritan Bennett 980 Series Ventilator System PB980 All models affected ARTG Number: 221416
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	3/02/2016
Responsible Entity	Covidien Pty Ltd
Reason/Issue	There have been reports of issues with the Graphical User Interface (GUI) & loss of primary ventilation. The GUI can become unresponsive to touch, but the ventilator continues to operate at existing settings, all real-time waveforms, pressure/volume measurements, alarm functions & the bezel keys remain active. However, users are unable to change ventilator settings/configuration of the display. Plus, under certain circumstances there is a loss of primary ventilation capabilities, in which the Backup Ventilation (BUV) design feature is activated. When BUV is initiated, high urgency audio & visual alarms are enunciated immediately & cannot be silenced. In some cases, the ventilator subsequently progressed to a ventilator inoperative condition, where the ventilator opens all valves to atmospheric pressure & room air, & ventilation ceases. High urgency audio/visual alarms are enunciated. There have been no reports of adverse health effects or death associated with the above situations.
Recall Action	Recall for Product Correction
Recall Action Instructions	Covidien is advising users that the continued use of the affected devices is appropriate. However, the decision to continue to use the affected devices should be made in the context of the individual patient’s clinical condition. If the reported defects occur, the clinical team should transfer the patient to anther ventilator. The manufacturer is working on a service update which will be implemented as soon as it becomes available. This action has been closed out on 17/01/2024
Contact Information	1800 350 702 - Medtronic Technical Support Department