Recall Z-1208-2018 ยท CBK Ventilator, Continuous, Facility Use
Covidien LLC
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.
| Date | Nov 21, 2017 |
| Status | Terminated |
| Reason | Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation. |
| Root cause | Process control |
| Action | Consignees are instructed to immediately notify all care environments in which the PB980 ventilators are used about the notification. If the facility has distributed PB980 ventilators to other persons or facilities, they are asked to please promptly forward a copy of the letter to those recipients. The consignee is asked to complete an attached form and return it as directed to confirm receipt and understanding of the notification.The firm developed a tool to inspect and identify the firmware on the batteries. Medtronic service engineers will inspect batteries at consignee facilities during sc |
| Quantity | 15,885 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the cou |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM Covidien, Feb 24, 2014 |