Recall Z-1895-2016 ยท CBK Ventilator, Continuous, Facility Use
Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
| Date | Jun 13, 2016 (initiated May 17, 2016) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 922 units total (501 units in US) |
| 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, Mexic |
| FDA record | Open on fda.gov |