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
Gas-Machine for Anesthesia - Product Code BSZ
원인
Ge healthcare has received reports of breathing circuit or tubing misconnections of the anesthesia delivery unit (adu), that may impact patient safety.
조치
A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.
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제품 설명
Datex-Ohmeda S/5 Anesthesia Delivery Unit || Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.