Puritan Bennett 980 Series Ventilator

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, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.

The firm notified consignees starting on March 25, 2022 via customer letter. Customers were informed of the issue and advised to institute workflow modifications to ensure visibility of the GUI visual alarm banner to ensure awareness of an active alarm condition in the absence of a functioning audible alarm and/or omni-directional LED visual alarm. If the audible alarm or omni-directional LED alarm fail, the clinical team should transfer the patient to another form of ventilation. The firm will correct the issue in a future software update. For questions contact your Medtronic representative or Technical Service at 1-800-255-6774 The firm sent additional correction notices to consignees that received affected devices before the software correction was distributed.