Date Initiated by Firm | November 04, 2021 |
Date Posted | December 09, 2021 |
Recall Status1 |
Terminated 3 on July 09, 2024 |
Recall Number | Z-0352-2022 |
Recall Event ID |
88987 |
510(K)Number | K193056 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
|
Product | Puritan Bennett 980 Series Ventilator, 980X3ENDIUU |
Code Information |
GTIN/UDI - 10884521172524
Serial Numbers:
35B1700308
35B1700311
35B1700361
35B1700363
35B1700364
35B1700366
35B1700368
35B1700369
35B1700370
35B1700371
35B1700373
35B1700375
35B1700376
35B1700377
35B1700378
35B1700379
35B1700380
35B1700382
35B1700383
35B1700385
35B1700386
35B1700389
35B1700390
35B1700391
35B1700392
35B1700394
35B1700395
35B1700398
35B1700400
35B1700401
35B1700402
35B1700404
35B1700410
35B1700414
35B1700415
35B1700417
35B1700421
35B1700422
35B1700423
35B1700424
35B1700433
35B1700441
35B1700444
35B1700446
35B1700448
35B1700450
35B1700454
35B1700455
35B1700463
35B1700466
35B1700491
35B1700497
35B1700498
35B1700500
35B1700506
35B1700515
35B1700521
35B1700523
35B1700524
35B1700528
35B1700532
35B1700535
35B1700550
35B1700556
35B1700571
35B1700607
35B1700620
35B1700666
35B1700989
35B1701004
35B1701015
35B1701417
35B1701419
35B1702698
35B1702873
35B1703371
35B1703383
35B1703421
35B1800480
35B1800511
35B1800522
35B1800531
|
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 |
|
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
|