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Gas Delivery Engine (GDE), 16650A recallZ-1896-2016 · Carefusion 211 Inc dba Carefusion · initiated May 17, 2016

Class I Terminated All recalls posted in June 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Carefusion 211 Inc dba Carefusion or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

FDA root cause category: Under Investigation by firm

What the company is doing

CareFusion sent a Field Safety Notice dated May 17, 2016, to all affected customers. The notice informed customers that CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). This malfunction creates a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation to the patient. By design an audible clinical alarm is activated. Customers were informed of the problems identified and the actions to be taken. Customers were not required to return the affected devices or suspend use, customers would receive an copy of the identified affected serial numbers, as well as a response card, customers were requested to promptly return the response card to expedite the correction process and acknowledge receipt of the notification, Customers would be contacted by CareFusion to arrange onsite remediation of the affected devices, in the interim if any AVEA ventilator unit in their facility exhibits a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support per the contact information listed below to report the issue. Customers with questions should call 888-562-6016, for technical support 800-231-2466 or [email protected].

Recall details

Recall number
Z-1896-2016
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 17, 2016
Posted by the FDA
Jun 13, 2016
Recalling firm
Carefusion 211 Inc dba Carefusion
Quantity
922 units total (501 units in US)
Product code
CBK
FDA submissions
K013642, K073069, K103211
Distribution
Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.

Product description

Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

Code information (models, lots, serial numbers)

n/a

Other devices under the same FDA submission

12 devices cleared under K013642, K073069, K103211 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 74111).

Sources and updates

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