Recall Z-0966-2022 ยท CBK Ventilator, Continuous, Facility Use
Medtronic formerly Covidien
Puritan Bennett 980 Series Ventilator
| Date | Apr 25, 2022 (initiated Mar 25, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 representativ |
| Quantity | 18,508 OUS; 18,412 US |
| Distribution | US Nationwide - Worldwide .Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193056 | Puritan Bennett 980 Series Ventilator System Covidien, LLC, Nov 20, 2020 |