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
Through customer complaints, maquet has been informed that servo-i ventilators have stopped to ventilate and have generated three different technical error codes.
조치
Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer.
The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators:
'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.
Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.'
Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual.
For further questions, please call (973) 709-7660.
Servo-i Ventilator Systems; Article number 64 87 800 || Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents.