U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Ventilator, continuous, facility use - Product Code CBK
원인
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain puritan bennett 980 ventilators may not fully charge after installation.
조치
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 scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced.
For further questions, please call (203) 492-5415.
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 countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam
제품 설명
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.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.