The FDA announced on January 3, 2022 a Class I recall, the most serious type of recall, of the Puritan Bennett 980 Series Ventilator that were distributed from February 23, 2017 to April 4, 2020. There are 135 affected devices in the United States (278 worldwide). The manufacturer initiated the recall on November 4, 2021.
Ventilators are machines that provide respiratory support by acting as bellows to move air in and out of the lungs. The ventilator is adjusted to control how often it pushes air into the lungs and how much air is provided.
Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended. If this occurs, it could result in the loss of ventilation and serious adverse events such as hypercarbia (an increase of carbon dioxide in the blood), hypoxemia (an abnormally low amount of oxygen in the bloodstream), neurological injury or death. There have been six complaints and one death regarding this device issue. There have been no reported injuries.
Medtronic describes its recalled ventilator as follows: “The Puritan Bennett™ 980 ventilator helps enable patients to breathe more naturally through some of the most innovative breath delivery technology available. Our simple, safe, and smart design provides more natural ventilation that may help improve patient comfort … The Puritan Bennett™ 980 ventilator provides a unique ventilator assurance feature which, in the event of certain system failures, will continue to deliver ventilatory support as close to the preset settings as feasible, and has an integrated expiratory filtration system. Advanced synchrony tools help clinicians set the ventilator to adapt to their patients’ unique needs and help provide the appropriate level of support throughout the breath.”
On November 4, 2021, Medtronic began to notify customers through Urgent Medical Device Correction letters of the device defect that may lead to the ventilator becoming inoperable during use. Medtronic advised customers as follows: “Actions you should take. Immediately discontinue use of the affected ventilators. Remove the affected ventilators from clinical service and quarantine the affected ventilators until such time that a Medtronic Technical Service Engineer inspects and replaces the affected printed circuit board assemblies. Notify all personnel in all care environments in which the affected PB980 series ventilators are used about this medical device correction. If your facility has distributed affected PB980 series ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. If you are aware of any incidents related to this issue, please contact our Technical Support Department immediately at 1-800-255-6774, option 4, and then option 1 to provide information regarding those events so regulatory reporting obligations can be fulfilled. Work with the Medtronic Technical Support Department if you require assistance finding alternative ventilation devices. Beginning November 5, 2021, Medtronic Technical Service will contact all affected customers to schedule a service appointment for all potentially affected ventilators. If you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.”
If you or a loved one suffered harm due to a defective ventilator or other medical device in the United States, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.
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