—#190183

Product

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

FDA product code: CBK — Ventilator, Continuous, Facility Use
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K193056
Affected lot / code info: GTIN/UDI - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663

Why it was recalled

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

On November 4, 2021, the firm began to notify customers through Urgent Medical Device Correction letters. Customers were informed of the device defect that may lead to the ventilator becoming inoperable during use. 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.

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide distribution - US Nationwide.

Timeline

Recall initiated: 2021-11-04
Posted by FDA: 2021-12-09
Terminated: 2024-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.