Puritan Bennett 560 Ventilator

Medtronic is issuing a voluntary medical device correction related to specific serial numbers of the turbine component of Puritan Bennett 500 series ventilators. This voluntary medical device correction is being issued following confirmation of six reports from customers where it was stated that the ventilator low pressure alarm annunciated, and the high priority indicator illuminated indicating a loss of gas supply resulting in the ventilator becoming inoperable.

In the event of a loss of gas supply resulting in an inoperable ventilator, the audible and visual alarms will alert a caregiver that an alternate form of ventilation is required. Loss of ventilation can lead to a delay of treatment, potentially resulting in hypoxia, dyspnea, or death. In the event the ventilator becomes inoperable, the patient should be transferred to another form of ventilation.

Medtronic is advising that continued use of pb500 ventilators is appropriate when the actions listed in the recall notification are taken into consideration unless this continued use is inconsistent with facility's internal policies and procedures.

Recall start date: August 23, 2022