Date Initiated by Firm | November 04, 2021 |
Date Posted | December 09, 2021 |
Recall Status1 |
Terminated 3 on July 09, 2024 |
Recall Number | Z-0348-2022 |
Recall Event ID |
88987 |
510(K)Number | K193056 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
|
Product | Puritan Bennett 980 Series Ventilator, 980X1ENNISB |
Code Information |
GTIN/UDI - 10884521171749
Serial Numbers:
35B1700430
35B1700442
35B1700456
35B1700510
35B1700514
35B1700520
35B1700553
35B1700554
35B1700559
35B1700561
35B1700608
|
Recalling Firm/ Manufacturer |
Covidien Llc 15 Hampshire St Mansfield MA 02048-1113
|
For Additional Information Contact | Technical Service 508-261-8000 |
Manufacturer Reason for Recall | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
FDA Determined Cause 2 | Reprocessing Controls |
Action | 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. |
Quantity in Commerce | 278 total |
Distribution | Worldwide distribution - US Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CBK
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